<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04426695</url>
  </required_header>
  <id_info>
    <org_study_id>R10933-10987-COV-2066</org_study_id>
    <secondary_id>2020-002537-15</secondary_id>
    <nct_id>NCT04426695</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for Hospitalized Adult Patients With COVID-19</brief_title>
  <official_title>A Master Protocol Assessing the Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Hospitalized Patients With COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Regeneron Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Regeneron Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objectives are:&#xD;
&#xD;
      Pooled Phase 3 (Cohort 1) and Phase 2 (Cohort 1A)&#xD;
&#xD;
        -  To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in&#xD;
           reducing viral load of SARS-CoV-2&#xD;
&#xD;
        -  To evaluate the clinical efficacy of REGN10933+REGN10987 compared to placebo, as&#xD;
           measured by death or mechanical ventilation&#xD;
&#xD;
      Phase 1/2 (Cohort 1)&#xD;
&#xD;
        -  To exclude futility of REGN10933+REGN10987 compared to placebo, as measured by death or&#xD;
           mechanical ventilation&#xD;
&#xD;
        -  To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 10, 2020</start_date>
  <completion_date type="Actual">October 22, 2021</completion_date>
  <primary_completion_date type="Actual">May 7, 2021</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Phase 1/Phase 2/Phase 3</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Based on Seronegative mFAS</measure>
    <time_frame>Day 1 to Day 7</time_frame>
    <description>Time-weighted average daily change from Day 1 to Day 7 in viral load (log10 copies/mL), as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on High Viral Load mFAS</measure>
    <time_frame>Day 6 to Day 29</time_frame>
    <description>Percentage of participants who died or went on mechanical ventilation from Day 6 through Day 29 based on high viral load mFAS were reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on Seronegative mFAS</measure>
    <time_frame>Day 6 to Day 29</time_frame>
    <description>Percentage of participants who died or went on mechanical ventilation from Day 6 through Day 29 based on seronegative mFAS were reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on Overall mFAS</measure>
    <time_frame>Day 6 to Day 29</time_frame>
    <description>Percentage of participants who died or went on mechanical ventilation from Day 6 through Day 29 based on overall FAS were reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on High Viral Load mFAS</measure>
    <time_frame>Day 1 to Day 29</time_frame>
    <description>Percentage of participants who died or went on mechanical ventilation from Day 1 through Day 29 based on high viral load mFAS were reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on Seronegative mFAS</measure>
    <time_frame>Day 1 to Day 29</time_frame>
    <description>Percentage of participants who died or went on mechanical ventilation from Day 1 through Day 29 based on seronegative mFAS were reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on Overall mFAS</measure>
    <time_frame>Day 1 to Day 29</time_frame>
    <description>Percentage of participants who died or went on mechanical ventilation from Day 1 through Day 29 based on overall mFAS were reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Treatment-Emergent Serious Adverse Events</measure>
    <time_frame>Up to Day 169</time_frame>
    <description>Treatment-emergent adverse events are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the observation period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Grade &gt;=2 Infusion Related Reactions up to Day 4</measure>
    <time_frame>Up to Day 4</time_frame>
    <description>Infusion-related reactions are defined as any relevant adverse event that occurs during the infusion or up to day 4. The severity of adverse events (including test findings classified as adverse events) were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Grade &gt;=2 Hypersensitivity Reactions Up to Day 29</measure>
    <time_frame>Up to Day 29</time_frame>
    <description>Hypersensitivity reactions are defined as any relevant adverse event that occurs during the infusion or up to study day 29. The severity of adverse events (including test findings classified as adverse events) were graded according to NCI-CTCAE.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Cumulative Incidence of Death or Mechanical Ventilation Based on Seronegative mFAS</measure>
    <time_frame>Up to Day 29</time_frame>
    <description>Cumulative incidence percentage was estimated using Kaplan-Meier method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Cumulative Incidence of Death or Mechanical Ventilation Based on High Viral Load mFAS</measure>
    <time_frame>Up to Day 29</time_frame>
    <description>Cumulative incidence percentage was estimated using Kaplan-Meier method.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on High Viral Load mFAS</measure>
    <time_frame>by Day 29</time_frame>
    <description>Percentage of participants who went on mechanical ventilation by Day 29 based on High Viral Load mFAS in pooled analysis phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on Seronegative mFAS</measure>
    <time_frame>by Day 29</time_frame>
    <description>Percentage of participants who went on mechanical ventilation at Day 29 based on Seronegative mFAS in pooled analysis phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on High Viral Load mFAS</measure>
    <time_frame>Day 6 to Day 29</time_frame>
    <description>Percentage of participants who died from Day 6 through Day 29 based on high viral load mFAS were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on Seronegative mFAS</measure>
    <time_frame>Day 6 to Day 29</time_frame>
    <description>Percentage of participants who died from Day 6 through Day 29 Based on seronegative mFAS in pooled analysis phase 3 (cohort 1) and phase 2 (cohort 1A) were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on High Viral Load mFAS</measure>
    <time_frame>Day 1 to Day 29</time_frame>
    <description>Percentage of participants who died from Day 1 through Day 29 based on High Viral Load mFAS in pooled analysis phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on Seronegative mFAS</measure>
    <time_frame>Day 1 to Day 29</time_frame>
    <description>Percentage of participants who died from Day 1 through Day 29 based on seronegative mFAS in pooled analysis phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on High Viral Load mFAS</measure>
    <time_frame>by Day 29</time_frame>
    <description>Percentage of participants who were discharged by Day 29 based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on Seronegative mFAS</measure>
    <time_frame>by Day 29</time_frame>
    <description>Percentage of participants who were discharged by Day 29 based on seronegative mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital Over Time Based on High Viral Load mFAS</measure>
    <time_frame>Up to Day 29</time_frame>
    <description>Percentage of participants who died or were readmitted to hospital over time based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A)were reported. Readmission to hospital was based on investigator report.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital by Day 29 Based on Seronegative mFAS</measure>
    <time_frame>by Day 29</time_frame>
    <description>Percentage of participants who died or were readmitted to hospital at Day 29 based on seronegative mFAS in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Readmission to hospital was based on investigator report.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death (ie, Overall Survival) by Day 29 Based on High Viral Load mFAS</measure>
    <time_frame>by Day 29</time_frame>
    <description>Overall Survival was defined as time interval from randomization to death. Percentage of participants with cumulative incidence of death (ie, overall survival) at Day 29 from randomization based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death (ie, Overall Survival) by Day 29 Based on Seronegative mFAS</measure>
    <time_frame>by Day 29</time_frame>
    <description>Overall Survival was defined as time interval from randomization to death. Percentage of participants with cumulative incidence of death (ie, overall survival) at Day 29 from randomization based on seronegative mFAS in phase 3 (Cohort 1) and phase 2 (Cohort 1A)were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on High Viral Load mFAS</measure>
    <time_frame>by Day 29</time_frame>
    <description>Number of participants with cumulative incidence of mechanical ventilation by Day 29 based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on Seronegative mFAS</measure>
    <time_frame>by Day 29</time_frame>
    <description>Percentage of participants with cumulative incidence of mechanical ventilation by Day 29 based on seronegative mFAS in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on High Viral Load mFAS</measure>
    <time_frame>by Day 29</time_frame>
    <description>Percentage of participants with cumulative incidence of death or mechanical ventilation by Day 29 based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on Seronegative mFAS</measure>
    <time_frame>by Day 29</time_frame>
    <description>Percentage of participants with cumulative incidence of death or mechanical ventilation by Day 29 based on seronegative mFAS in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on High Viral Load mFAS</measure>
    <time_frame>Up to Day 56</time_frame>
    <description>Time to discharge from hospital based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on Seronegative mFAS</measure>
    <time_frame>Up to Day 56</time_frame>
    <description>Time to discharge from hospital based on Seronegative mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants With Treatment-Emergent Serious Adverse Events</measure>
    <time_frame>Up to Day 169</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants With Grade &gt;=2 Infusion Related Reactions up to Day 4</measure>
    <time_frame>Up to Day 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants With Grade &gt;=2 Hypersensitivity Reactions Up to Day 29</measure>
    <time_frame>Up to Day 29</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on Seronegative mFAS</measure>
    <time_frame>by Day 29</time_frame>
    <description>Percentage of participants who went on mechanical ventilation in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on Seronegative mFAS</measure>
    <time_frame>Day 6 to Day 29</time_frame>
    <description>Percentage of participants who died from Day 6 through Day 29 in phase 3 (cohort 1) and phase 2 (cohort 1A) were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on Seronegative mFAS</measure>
    <time_frame>Day 1 to Day 29</time_frame>
    <description>Percentage of participants who died from Day 1 through Day 29 in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on Seronegative mFAS</measure>
    <time_frame>by Day 29</time_frame>
    <description>Percentage of participants who were discharged in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) by Day 29 were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital by Day 29 Based on Seronegative mFAS</measure>
    <time_frame>Up to Day 29</time_frame>
    <description>Percentage of participants who died or were readmitted to hospital in phase 3 (Cohort 1) and phase 2 (Cohort 1A) by Day 29 were reported. Readmission to hospital was based on investigator report.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death up to Day 29 Based on Seronegative mFAS</measure>
    <time_frame>Up to Day 29</time_frame>
    <description>Percentage of participants with cumulative incidence of death in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) up to Day 29 from randomization were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on Seronegative mFAS</measure>
    <time_frame>by Day 29</time_frame>
    <description>Percentage of participants with cumulative incidence of mechanical ventilation in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) by Day 29 were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on Seronegative mFAS</measure>
    <time_frame>by Day 29</time_frame>
    <description>Percentage of participants with cumulative incidence of death or mechanical ventilation in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) by Day 29 were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on Seronegative mFAS</measure>
    <time_frame>Up to Day 56</time_frame>
    <description>Time to discharge from hospital up to Day 56 was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: TWA Change From Baseline Viral Load (Seronegative mFAS) in NP Samples up to Day 11 Based on Seronegative mFAS</measure>
    <time_frame>Day 1 to Day 11</time_frame>
    <description>TWA change from baseline in viral load up to Day 11 was calculated for each participant using the trapezoidal rule as the area under the curve for change from baseline at each time point divided by the time interval for the observation period. TWA change from baseline viral load in NP samples through Day 11, was measured by RT-qPCR in NP swab samples was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicate improvement in viral load.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: TWA Change From Baseline Viral Load (Seronegative mFAS) in NP Samples up to Day 29</measure>
    <time_frame>Day 1 to Day 29</time_frame>
    <description>TWA change from baseline in viral load up to Day 29 was calculated for each participant using the trapezoidal rule as the area under the curve for change from baseline at each time point divided by the time interval for the observation period. TWA change from baseline viral load in NP samples through Day 29, was measured by quantitative RT-qPCR in NP swab samples was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicate improvement in viral load.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time</measure>
    <time_frame>Days 3, 5, 7, 9, 11, 13, 15, 22 and 29</time_frame>
    <description>Change from baseline in viral load as measured by RT-qPCR in NP swabs over time was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicates improvement in viral load.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time</measure>
    <time_frame>Days 3, 5, 7, 9, 11, 13, 15, 22 and 29</time_frame>
    <description>Percent change from baseline in viral load as measured by RT-qPCR in NP swabs over time was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicates improvement in viral load.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on High Viral Load mFAS</measure>
    <time_frame>by Day 29</time_frame>
    <description>Percentage of participants who went on mechanical ventilation in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 to Day 29 Based on High Viral Load mFAS</measure>
    <time_frame>Day 6 to Day 29</time_frame>
    <description>Percentage of participants who died in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 to Day 29 Based on High Viral Load mFAS</measure>
    <time_frame>Day 1 to Day 29</time_frame>
    <description>Percentage of participants who died in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on High Viral Load mFAS</measure>
    <time_frame>by Day 29</time_frame>
    <description>Percentage of participants who were discharged in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital Over Time Based on High Viral Load mFAS</measure>
    <time_frame>Up to Day 29</time_frame>
    <description>Percentage of participants who died or were readmitted to hospital in phase 3 (Cohort 1) and phase 2 (Cohort 1A) over time were reported. Readmission to hospital was based on investigator report.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death Over Time Based on High Viral Load mFAS</measure>
    <time_frame>Up to Day 29</time_frame>
    <description>Cumulative Incidence of Death Over Time in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation Over Time Based on High Viral Load mFAS</measure>
    <time_frame>Up to Day 29</time_frame>
    <description>Cumulative Incidence of Mechanical Ventilation Over Time in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation Over Time Based on High Viral Load mFAS</measure>
    <time_frame>Up to Day 29</time_frame>
    <description>Cumulative Incidence of Death or Mechanical Ventilation Over Time in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge Based on High Viral Load mFAS</measure>
    <time_frame>Up to Day 56</time_frame>
    <description>Time to Discharge in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Over Time Based on Seronegative mFAS</measure>
    <time_frame>Up to Day 29</time_frame>
    <description>Time-weighted average daily change over time up to Day 29 in viral load (log10 copies/mL), as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Change From Baseline as Measured by RT-qPCR in NP Swabs Over Time Based on Seronegative mFAS</measure>
    <time_frame>Days 3, 5, 7, 9, 11, 13, 15, 22 and 29</time_frame>
    <description>Change from baseline in viral load as measured by RT-qPCR in NP swabs over time was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicates improvement in viral load.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1 [Cohort 1] and Phase 2 [Cohort 1]: Percentage of Participants Who Died or Went On Mechanical Ventilation by Day 29 Based on Seronegative mFAS</measure>
    <time_frame>Through Day 29</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1 [Cohort 1] and Phase 2 [Cohort 1]: Percentage of Participants Who Died or Went On Mechanical Ventilation by Day 29 Based on High Viral Load mFAS</measure>
    <time_frame>Through Day 29</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1 [Cohort 1]: Area Under the Concentration-Time Curve From Time 0 to 28 Days Post-dose (AUC0-28)</measure>
    <time_frame>Up to Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration at the End of Infusion (Ceoi)</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration at Day 28 (C28)</measure>
    <time_frame>Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933</measure>
    <time_frame>Through Day 169</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987</measure>
    <time_frame>Through Day 169</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity as Measured by Neutralizing Antibody Status (NAb) to REGN10933</measure>
    <time_frame>Through Day 57</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity as Measured by Neutralizing Antibody Status (NAb) to REGN10987</measure>
    <time_frame>Through Day 57</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">2252</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>On Low-Flow Oxygen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cohort 1 (C1): O2 saturation &gt;93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device</description>
  </arm_group>
  <arm_group>
    <arm_group_label>With COVID-19 symptoms but not requiring supplemental O2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cohort 1A (C1A): With COVID-19 symptoms but not requiring supplemental oxygen</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High O2 No Mechanical Ventilation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cohort 2 (C2): On high-intensity oxygen (O2) therapy but not on mechanical ventilation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>On Mechanical Ventilation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cohort 3 (C3): On mechanical ventilation</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>REGN10933+REGN10987 combination therapy</intervention_name>
    <description>Administered intravenously (IV) single dose</description>
    <arm_group_label>High O2 No Mechanical Ventilation</arm_group_label>
    <arm_group_label>On Low-Flow Oxygen</arm_group_label>
    <arm_group_label>On Mechanical Ventilation</arm_group_label>
    <arm_group_label>With COVID-19 symptoms but not requiring supplemental O2</arm_group_label>
    <other_name>REGN-COV2</other_name>
    <other_name>REGEN-COV™</other_name>
    <other_name>Ronapreve™</other_name>
    <other_name>casirivimab</other_name>
    <other_name>imdevimab</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo IV Single Dose</description>
    <arm_group_label>High O2 No Mechanical Ventilation</arm_group_label>
    <arm_group_label>On Low-Flow Oxygen</arm_group_label>
    <arm_group_label>On Mechanical Ventilation</arm_group_label>
    <arm_group_label>With COVID-19 symptoms but not requiring supplemental O2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Has SARS-CoV-2-positive antigen or molecular diagnostic test (by validated SARS-CoV-2&#xD;
             antigen, RT-PCR, or other molecular diagnostic assay, using an appropriate sample such&#xD;
             as NP, nasal, oropharyngeal [OP], or saliva) ≤72 hours prior to randomization and no&#xD;
             alternative explanation for current clinical condition. A historical record of&#xD;
             positive result from test conducted ≤72 hours prior to randomization is acceptable.&#xD;
&#xD;
          -  Has symptoms consistent with COVID-19, as determined by investigator, with onset ≤10&#xD;
             days before randomization&#xD;
&#xD;
          -  Hospitalized for ≤72 hours with at least 1 of the following at randomization; patients&#xD;
             meeting more than one criterion will be categorized in the most severely affected&#xD;
             category:&#xD;
&#xD;
               1. Cohort 1A: With COVID-19 symptoms but not requiring supplemental oxygen&#xD;
&#xD;
               2. Cohort 1: Maintains O2 saturation &gt;93% on low-flow oxygen as defined in the&#xD;
                  protocol&#xD;
&#xD;
               3. Cohort 2: High-intensity oxygen therapy without mechanical ventilation as defined&#xD;
                  in the protocol&#xD;
&#xD;
               4. Cohort 3: On mechanical ventilation&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Phase 1 Only: Patients maintaining O2 saturation &gt;94% on room air&#xD;
&#xD;
          -  In the opinion of the investigator, unlikely to survive for &gt;48 hours from screening&#xD;
&#xD;
          -  Receiving extracorporeal membrane oxygenation (ECMO)&#xD;
&#xD;
          -  Has new-onset stroke or seizure disorder during hospitalization&#xD;
&#xD;
          -  Initiated on renal replacement therapy due to COVID-19&#xD;
&#xD;
        NOTE: Other protocol defined inclusion / exclusion criteria apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Trial Management</last_name>
    <role>Study Director</role>
    <affiliation>Regeneron Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35249</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Chandler</city>
        <state>Arizona</state>
        <zip>85224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site 1</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Mission Hills</city>
        <state>California</state>
        <zip>91345</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33486</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Fort Pierce</city>
        <state>Florida</state>
        <zip>34982</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Pensacola</city>
        <state>Florida</state>
        <zip>32504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Glenview</city>
        <state>Illinois</state>
        <zip>60026</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Urbana</city>
        <state>Illinois</state>
        <zip>61801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40217</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Chesterfield</city>
        <state>Missouri</state>
        <zip>63017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68198-5400</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Englewood</city>
        <state>New Jersey</state>
        <zip>07631</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Morristown</city>
        <state>New Jersey</state>
        <zip>07960</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Neptune</city>
        <state>New Jersey</state>
        <zip>07753</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Pennington</city>
        <state>New Jersey</state>
        <zip>08534</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Summit</city>
        <state>New Jersey</state>
        <zip>07901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Teaneck</city>
        <state>New Jersey</state>
        <zip>07666</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10451</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site 1</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site 2</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Jamaica</city>
        <state>New York</state>
        <zip>11432</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10019</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>West Islip</city>
        <state>New York</state>
        <zip>11795</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>White Plains</city>
        <state>New York</state>
        <zip>10601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Greensboro</city>
        <state>North Carolina</state>
        <zip>27408</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45409</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19140</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02906</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site 1</name>
      <address>
        <city>Amarillo</city>
        <state>Texas</state>
        <zip>79106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site 2</name>
      <address>
        <city>Amarillo</city>
        <state>Texas</state>
        <zip>79106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Lubbock</city>
        <state>Texas</state>
        <zip>79410</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Sugar Land</city>
        <state>Texas</state>
        <zip>77479</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Tyler</city>
        <state>Texas</state>
        <zip>75701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Everett</city>
        <state>Washington</state>
        <zip>98201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site 1</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Salvador</city>
        <state>Bahia</state>
        <zip>40170-130</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Fortaleza</city>
        <state>Ceara</state>
        <zip>60160-230</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Curitiba</city>
        <state>Paraná</state>
        <zip>80810-040</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande Do Sul</state>
        <zip>90610-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Passo Fundo</city>
        <state>RS</state>
        <zip>99010-170</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Chapeco</city>
        <state>Santa Catarina</state>
        <zip>89801-355</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Criciuma</city>
        <state>Santa Catarina</state>
        <zip>88811-508</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Botucatu</city>
        <state>Sao Paolo</state>
        <zip>18618-686</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Campinas</city>
        <state>Sao Paolo</state>
        <zip>13060-080</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>São Paulo</city>
        <zip>02401- 400</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>São Paulo</city>
        <zip>04012-909</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>São Paulo</city>
        <zip>05403-010</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site 1</name>
      <address>
        <city>Las Condes</city>
        <state>Santiago De Chile</state>
        <zip>7591047</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site 2</name>
      <address>
        <city>Las Condes</city>
        <state>Santiago De Chile</state>
        <zip>7591047</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Vitacura</city>
        <state>Santiago De Chile</state>
        <zip>7650568</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Santiago de Chile</city>
        <zip>7500691</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Guadalajara</city>
        <state>Jalisco</state>
        <zip>44340</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Monterrey</city>
        <state>Nuevo Leon</state>
        <zip>64718</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Culiacán</city>
        <state>Sinaloa</state>
        <zip>80020</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Culiacan</city>
        <zip>80230</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Monterrey</city>
        <zip>64060</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site 1</name>
      <address>
        <city>Mérida</city>
        <zip>97000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site 2</name>
      <address>
        <city>Mérida</city>
        <zip>97000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Veracruz</city>
        <zip>91700</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Zapopan</city>
        <zip>45170</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Chisinau</city>
        <zip>MD-2025</zip>
        <country>Moldova, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Bucuresti</city>
        <zip>021105</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
    <country>Chile</country>
    <country>Mexico</country>
    <country>Moldova, Republic of</country>
    <country>Romania</country>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <results_first_submitted>May 5, 2022</results_first_submitted>
  <results_first_submitted_qc>June 28, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">July 25, 2022</results_first_posted>
  <last_update_submitted>January 25, 2023</last_update_submitted>
  <last_update_submitted_qc>January 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Coronavirus disease 2019 (COVID-19)</keyword>
  <keyword>Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2)</keyword>
  <keyword>coronavirus</keyword>
  <keyword>acute respiratory distress syndrome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Casirivimab and imdevimab drug combination</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification</ipd_time_frame>
    <ipd_access_criteria>Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).</ipd_access_criteria>
    <ipd_url>https://vivli.org/</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 27, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/95/NCT04426695/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 7, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/95/NCT04426695/SAP_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>A total of 2324 participants were screened and 2203 participants randomized and treated, 49 participants were randomized but not treated, and 72 discontinued at the screening phase. Reasons for discontinuation at screening phase: 54 - Screen Failure, 10 - Subject Decision, 1- Sponsor Request, 7- Other.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Phase 1: Cohort 1 (Placebo)</title>
          <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 1 (Cohort 1).</description>
        </group>
        <group group_id="P2">
          <title>Phase 1: Cohort 1 (R10933+R10987 2400 mg IV)</title>
          <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 milligrams (mg) intravenously on Day 1 in Phase 1 (Cohort 1).</description>
        </group>
        <group group_id="P3">
          <title>Phase 1: Cohort 1 (R10933+R10987 8000 mg IV)</title>
          <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 1 (Cohort 1).</description>
        </group>
        <group group_id="P4">
          <title>Phase 2: Cohort 1 (Placebo)</title>
          <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 1)</description>
        </group>
        <group group_id="P5">
          <title>Phase 2: Cohort 1 (R10933+R10987 2400 mg</title>
          <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 milligrams (mg) intravenously on Day 1 in Phase 2 (Cohort 1)</description>
        </group>
        <group group_id="P6">
          <title>Phase 2: Cohort 1 (R10933+R10987 8000 mg IV)</title>
          <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 1)</description>
        </group>
        <group group_id="P7">
          <title>Phase 3: Cohort 1 (Placebo)</title>
          <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1)</description>
        </group>
        <group group_id="P8">
          <title>Phase 3: Cohort 1 (R10933+R10987 2400 mg)</title>
          <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 milligrams (mg) intravenously on Day 1 in Phase 3 (Cohort 1)</description>
        </group>
        <group group_id="P9">
          <title>Phase 3: Cohort 1 (R10933+R10987 8000 mg IV)</title>
          <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 3 (Cohort 1)</description>
        </group>
        <group group_id="P10">
          <title>Phase 2: Cohort 1A (Placebo)</title>
          <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
        </group>
        <group group_id="P11">
          <title>Phase 2: Cohort 1A (R10933+R10987 2400 mg IV)</title>
          <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
        </group>
        <group group_id="P12">
          <title>Phase 2: Cohort 1A (R10933+R10987 8000 mg IV)</title>
          <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
        </group>
        <group group_id="P13">
          <title>Phase 2: Cohort 2 (Placebo)</title>
          <description>Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 2).</description>
        </group>
        <group group_id="P14">
          <title>Phase 2: Cohort 2 (R10933+R10987 2400 mg IV)</title>
          <description>Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 2).</description>
        </group>
        <group group_id="P15">
          <title>Phase 2: Cohort 2 (R10933+R10987 8000 mg IV)</title>
          <description>Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 2).</description>
        </group>
        <group group_id="P16">
          <title>Phase 2: Cohort 3 (Placebo)</title>
          <description>Participants on mechanical ventilation received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 3).</description>
        </group>
        <group group_id="P17">
          <title>Phase 2: Cohort 3 (R10933+R10987 2400 mg IV)</title>
          <description>Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).</description>
        </group>
        <group group_id="P18">
          <title>Phase 2: Cohort 3 (R10933+R10987 8000 mg IV)</title>
          <description>Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="19"/>
                <participants group_id="P3" count="20"/>
                <participants group_id="P4" count="208"/>
                <participants group_id="P5" count="211"/>
                <participants group_id="P6" count="210"/>
                <participants group_id="P7" count="251"/>
                <participants group_id="P8" count="252"/>
                <participants group_id="P9" count="252"/>
                <participants group_id="P10" count="201"/>
                <participants group_id="P11" count="205"/>
                <participants group_id="P12" count="203"/>
                <participants group_id="P13" count="52"/>
                <participants group_id="P14" count="58"/>
                <participants group_id="P15" count="54"/>
                <participants group_id="P16" count="12"/>
                <participants group_id="P17" count="12"/>
                <participants group_id="P18" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="18"/>
                <participants group_id="P3" count="20"/>
                <participants group_id="P4" count="204"/>
                <participants group_id="P5" count="206"/>
                <participants group_id="P6" count="205"/>
                <participants group_id="P7" count="247"/>
                <participants group_id="P8" count="246"/>
                <participants group_id="P9" count="246"/>
                <participants group_id="P10" count="198"/>
                <participants group_id="P11" count="202"/>
                <participants group_id="P12" count="197"/>
                <participants group_id="P13" count="51"/>
                <participants group_id="P14" count="56"/>
                <participants group_id="P15" count="54"/>
                <participants group_id="P16" count="12"/>
                <participants group_id="P17" count="12"/>
                <participants group_id="P18" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="16"/>
                <participants group_id="P4" count="146"/>
                <participants group_id="P5" count="153"/>
                <participants group_id="P6" count="148"/>
                <participants group_id="P7" count="186"/>
                <participants group_id="P8" count="195"/>
                <participants group_id="P9" count="189"/>
                <participants group_id="P10" count="157"/>
                <participants group_id="P11" count="165"/>
                <participants group_id="P12" count="166"/>
                <participants group_id="P13" count="33"/>
                <participants group_id="P14" count="28"/>
                <participants group_id="P15" count="31"/>
                <participants group_id="P16" count="5"/>
                <participants group_id="P17" count="4"/>
                <participants group_id="P18" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="62"/>
                <participants group_id="P5" count="58"/>
                <participants group_id="P6" count="62"/>
                <participants group_id="P7" count="65"/>
                <participants group_id="P8" count="57"/>
                <participants group_id="P9" count="63"/>
                <participants group_id="P10" count="44"/>
                <participants group_id="P11" count="40"/>
                <participants group_id="P12" count="37"/>
                <participants group_id="P13" count="19"/>
                <participants group_id="P14" count="30"/>
                <participants group_id="P15" count="23"/>
                <participants group_id="P16" count="7"/>
                <participants group_id="P17" count="8"/>
                <participants group_id="P18" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="27"/>
                <participants group_id="P5" count="25"/>
                <participants group_id="P6" count="21"/>
                <participants group_id="P7" count="42"/>
                <participants group_id="P8" count="23"/>
                <participants group_id="P9" count="37"/>
                <participants group_id="P10" count="14"/>
                <participants group_id="P11" count="8"/>
                <participants group_id="P12" count="7"/>
                <participants group_id="P13" count="13"/>
                <participants group_id="P14" count="25"/>
                <participants group_id="P15" count="19"/>
                <participants group_id="P16" count="7"/>
                <participants group_id="P17" count="8"/>
                <participants group_id="P18" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="19"/>
                <participants group_id="P5" count="10"/>
                <participants group_id="P6" count="14"/>
                <participants group_id="P7" count="5"/>
                <participants group_id="P8" count="14"/>
                <participants group_id="P9" count="10"/>
                <participants group_id="P10" count="11"/>
                <participants group_id="P11" count="12"/>
                <participants group_id="P12" count="6"/>
                <participants group_id="P13" count="2"/>
                <participants group_id="P14" count="2"/>
                <participants group_id="P15" count="2"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
                <participants group_id="P18" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="12"/>
                <participants group_id="P5" count="18"/>
                <participants group_id="P6" count="22"/>
                <participants group_id="P7" count="13"/>
                <participants group_id="P8" count="13"/>
                <participants group_id="P9" count="10"/>
                <participants group_id="P10" count="15"/>
                <participants group_id="P11" count="16"/>
                <participants group_id="P12" count="17"/>
                <participants group_id="P13" count="2"/>
                <participants group_id="P14" count="1"/>
                <participants group_id="P15" count="2"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
                <participants group_id="P18" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="1"/>
                <participants group_id="P12" count="1"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
                <participants group_id="P18" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Sponsor Request</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
                <participants group_id="P18" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="1"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="1"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
                <participants group_id="P18" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Randomized but Never Treated</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="5"/>
                <participants group_id="P6" count="5"/>
                <participants group_id="P7" count="4"/>
                <participants group_id="P8" count="6"/>
                <participants group_id="P9" count="6"/>
                <participants group_id="P10" count="3"/>
                <participants group_id="P11" count="3"/>
                <participants group_id="P12" count="6"/>
                <participants group_id="P13" count="1"/>
                <participants group_id="P14" count="2"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
                <participants group_id="P18" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The full analysis set (FAS) included all randomized participants who received at least one dose (full or partial) of the study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>Phase 1: Cohort 1 (Placebo)</title>
          <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 1 (Cohort 1)</description>
        </group>
        <group group_id="B2">
          <title>Phase 1: Cohort 1 (R10933+R10987 2400 mg IV)</title>
          <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 1 (Cohort 1)</description>
        </group>
        <group group_id="B3">
          <title>Phase 1: Cohort 1 (R10933+R10987 8000 mg IV)</title>
          <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 1 (Cohort 1)</description>
        </group>
        <group group_id="B4">
          <title>Phase 2: Cohort 1 (Placebo)</title>
          <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 1)</description>
        </group>
        <group group_id="B5">
          <title>Phase 2: Cohort 1 (R10933+R10987 2400 mg IV)</title>
          <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 1)</description>
        </group>
        <group group_id="B6">
          <title>Phase 2: Cohort 1 (R10933+R10987 8000 mg IV)</title>
          <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 1)</description>
        </group>
        <group group_id="B7">
          <title>Phase 3: Cohort 1 (Placebo)</title>
          <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1).</description>
        </group>
        <group group_id="B8">
          <title>Phase 3: Cohort 1 (R10933+R10987 2400 mg IV)</title>
          <description>Phase 1: Cohort 1 (R10933+R10987 2400 mg IV)Edit Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1.</description>
        </group>
        <group group_id="B9">
          <title>Phase 3: Cohort 1 (R10933+R10987 8000 mg IV)</title>
          <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 3 (Cohort 1)</description>
        </group>
        <group group_id="B10">
          <title>Phase 2: Cohort 1A (Placebo)</title>
          <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
        </group>
        <group group_id="B11">
          <title>Phase 2: Cohort 1A (R10933+R10987 2400 mg IV)</title>
          <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
        </group>
        <group group_id="B12">
          <title>Phase 2: Cohort 1A (R10933+R10987 8000 mg IV)</title>
          <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
        </group>
        <group group_id="B13">
          <title>Phase 2: Cohort 2 (Placebo)</title>
          <description>Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 2).</description>
        </group>
        <group group_id="B14">
          <title>Phase 2: Cohort 2 (R10933+R10987 2400 mg IV)</title>
          <description>Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 2).</description>
        </group>
        <group group_id="B15">
          <title>Phase 2: Cohort 2 (R10933+R10987 8000 mg IV)</title>
          <description>Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 2).</description>
        </group>
        <group group_id="B16">
          <title>Phase 2: Cohort 3 (Placebo)</title>
          <description>Participants on mechanical ventilation received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 3).</description>
        </group>
        <group group_id="B17">
          <title>Phase 2: Cohort 3 (R10933+R10987 2400 mg IV)</title>
          <description>Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).</description>
        </group>
        <group group_id="B18">
          <title>Phase 2: Cohort 3 (R10933+R10987 8000 mg IV)</title>
          <description>Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).</description>
        </group>
        <group group_id="B19">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="18"/>
            <count group_id="B2" value="18"/>
            <count group_id="B3" value="20"/>
            <count group_id="B4" value="204"/>
            <count group_id="B5" value="206"/>
            <count group_id="B6" value="205"/>
            <count group_id="B7" value="247"/>
            <count group_id="B8" value="246"/>
            <count group_id="B9" value="246"/>
            <count group_id="B10" value="198"/>
            <count group_id="B11" value="202"/>
            <count group_id="B12" value="197"/>
            <count group_id="B13" value="51"/>
            <count group_id="B14" value="56"/>
            <count group_id="B15" value="54"/>
            <count group_id="B16" value="12"/>
            <count group_id="B17" value="12"/>
            <count group_id="B18" value="11"/>
            <count group_id="B19" value="2203"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Age: 18- &lt;40 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="26"/>
                    <measurement group_id="B5" value="16"/>
                    <measurement group_id="B6" value="17"/>
                    <measurement group_id="B7" value="29"/>
                    <measurement group_id="B8" value="28"/>
                    <measurement group_id="B9" value="14"/>
                    <measurement group_id="B10" value="22"/>
                    <measurement group_id="B11" value="20"/>
                    <measurement group_id="B12" value="20"/>
                    <measurement group_id="B13" value="4"/>
                    <measurement group_id="B14" value="4"/>
                    <measurement group_id="B15" value="6"/>
                    <measurement group_id="B16" value="0"/>
                    <measurement group_id="B17" value="1"/>
                    <measurement group_id="B18" value="1"/>
                    <measurement group_id="B19" value="212"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age: 40- &lt;65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="82"/>
                    <measurement group_id="B5" value="99"/>
                    <measurement group_id="B6" value="96"/>
                    <measurement group_id="B7" value="105"/>
                    <measurement group_id="B8" value="119"/>
                    <measurement group_id="B9" value="127"/>
                    <measurement group_id="B10" value="82"/>
                    <measurement group_id="B11" value="101"/>
                    <measurement group_id="B12" value="91"/>
                    <measurement group_id="B13" value="30"/>
                    <measurement group_id="B14" value="23"/>
                    <measurement group_id="B15" value="24"/>
                    <measurement group_id="B16" value="6"/>
                    <measurement group_id="B17" value="4"/>
                    <measurement group_id="B18" value="5"/>
                    <measurement group_id="B19" value="1021"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age: &gt;=65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="96"/>
                    <measurement group_id="B5" value="91"/>
                    <measurement group_id="B6" value="92"/>
                    <measurement group_id="B7" value="113"/>
                    <measurement group_id="B8" value="99"/>
                    <measurement group_id="B9" value="105"/>
                    <measurement group_id="B10" value="94"/>
                    <measurement group_id="B11" value="81"/>
                    <measurement group_id="B12" value="86"/>
                    <measurement group_id="B13" value="17"/>
                    <measurement group_id="B14" value="29"/>
                    <measurement group_id="B15" value="24"/>
                    <measurement group_id="B16" value="6"/>
                    <measurement group_id="B17" value="7"/>
                    <measurement group_id="B18" value="5"/>
                    <measurement group_id="B19" value="970"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="90"/>
                    <measurement group_id="B5" value="98"/>
                    <measurement group_id="B6" value="98"/>
                    <measurement group_id="B7" value="113"/>
                    <measurement group_id="B8" value="112"/>
                    <measurement group_id="B9" value="115"/>
                    <measurement group_id="B10" value="91"/>
                    <measurement group_id="B11" value="87"/>
                    <measurement group_id="B12" value="89"/>
                    <measurement group_id="B13" value="17"/>
                    <measurement group_id="B14" value="20"/>
                    <measurement group_id="B15" value="20"/>
                    <measurement group_id="B16" value="8"/>
                    <measurement group_id="B17" value="4"/>
                    <measurement group_id="B18" value="2"/>
                    <measurement group_id="B19" value="990"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="114"/>
                    <measurement group_id="B5" value="108"/>
                    <measurement group_id="B6" value="107"/>
                    <measurement group_id="B7" value="134"/>
                    <measurement group_id="B8" value="134"/>
                    <measurement group_id="B9" value="131"/>
                    <measurement group_id="B10" value="107"/>
                    <measurement group_id="B11" value="115"/>
                    <measurement group_id="B12" value="108"/>
                    <measurement group_id="B13" value="34"/>
                    <measurement group_id="B14" value="36"/>
                    <measurement group_id="B15" value="34"/>
                    <measurement group_id="B16" value="4"/>
                    <measurement group_id="B17" value="8"/>
                    <measurement group_id="B18" value="9"/>
                    <measurement group_id="B19" value="1213"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="49"/>
                    <measurement group_id="B5" value="50"/>
                    <measurement group_id="B6" value="52"/>
                    <measurement group_id="B7" value="92"/>
                    <measurement group_id="B8" value="94"/>
                    <measurement group_id="B9" value="82"/>
                    <measurement group_id="B10" value="38"/>
                    <measurement group_id="B11" value="53"/>
                    <measurement group_id="B12" value="40"/>
                    <measurement group_id="B13" value="13"/>
                    <measurement group_id="B14" value="22"/>
                    <measurement group_id="B15" value="18"/>
                    <measurement group_id="B16" value="6"/>
                    <measurement group_id="B17" value="5"/>
                    <measurement group_id="B18" value="4"/>
                    <measurement group_id="B19" value="647"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="144"/>
                    <measurement group_id="B5" value="148"/>
                    <measurement group_id="B6" value="146"/>
                    <measurement group_id="B7" value="146"/>
                    <measurement group_id="B8" value="140"/>
                    <measurement group_id="B9" value="155"/>
                    <measurement group_id="B10" value="148"/>
                    <measurement group_id="B11" value="138"/>
                    <measurement group_id="B12" value="143"/>
                    <measurement group_id="B13" value="35"/>
                    <measurement group_id="B14" value="33"/>
                    <measurement group_id="B15" value="30"/>
                    <measurement group_id="B16" value="6"/>
                    <measurement group_id="B17" value="7"/>
                    <measurement group_id="B18" value="7"/>
                    <measurement group_id="B19" value="1453"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="11"/>
                    <measurement group_id="B5" value="8"/>
                    <measurement group_id="B6" value="7"/>
                    <measurement group_id="B7" value="9"/>
                    <measurement group_id="B8" value="12"/>
                    <measurement group_id="B9" value="9"/>
                    <measurement group_id="B10" value="12"/>
                    <measurement group_id="B11" value="11"/>
                    <measurement group_id="B12" value="14"/>
                    <measurement group_id="B13" value="3"/>
                    <measurement group_id="B14" value="1"/>
                    <measurement group_id="B15" value="6"/>
                    <measurement group_id="B16" value="0"/>
                    <measurement group_id="B17" value="0"/>
                    <measurement group_id="B18" value="0"/>
                    <measurement group_id="B19" value="103"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="9"/>
                    <measurement group_id="B8" value="9"/>
                    <measurement group_id="B9" value="13"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="1"/>
                    <measurement group_id="B14" value="0"/>
                    <measurement group_id="B15" value="0"/>
                    <measurement group_id="B16" value="0"/>
                    <measurement group_id="B17" value="0"/>
                    <measurement group_id="B18" value="0"/>
                    <measurement group_id="B19" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="7"/>
                    <measurement group_id="B6" value="6"/>
                    <measurement group_id="B7" value="6"/>
                    <measurement group_id="B8" value="10"/>
                    <measurement group_id="B9" value="9"/>
                    <measurement group_id="B10" value="11"/>
                    <measurement group_id="B11" value="8"/>
                    <measurement group_id="B12" value="6"/>
                    <measurement group_id="B13" value="2"/>
                    <measurement group_id="B14" value="2"/>
                    <measurement group_id="B15" value="1"/>
                    <measurement group_id="B16" value="1"/>
                    <measurement group_id="B17" value="1"/>
                    <measurement group_id="B18" value="0"/>
                    <measurement group_id="B19" value="78"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="1"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="1"/>
                    <measurement group_id="B13" value="1"/>
                    <measurement group_id="B14" value="1"/>
                    <measurement group_id="B15" value="0"/>
                    <measurement group_id="B16" value="1"/>
                    <measurement group_id="B17" value="0"/>
                    <measurement group_id="B18" value="0"/>
                    <measurement group_id="B19" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="34"/>
                    <measurement group_id="B5" value="21"/>
                    <measurement group_id="B6" value="33"/>
                    <measurement group_id="B7" value="26"/>
                    <measurement group_id="B8" value="32"/>
                    <measurement group_id="B9" value="25"/>
                    <measurement group_id="B10" value="27"/>
                    <measurement group_id="B11" value="32"/>
                    <measurement group_id="B12" value="25"/>
                    <measurement group_id="B13" value="7"/>
                    <measurement group_id="B14" value="6"/>
                    <measurement group_id="B15" value="9"/>
                    <measurement group_id="B16" value="1"/>
                    <measurement group_id="B17" value="1"/>
                    <measurement group_id="B18" value="3"/>
                    <measurement group_id="B19" value="295"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="136"/>
                    <measurement group_id="B5" value="146"/>
                    <measurement group_id="B6" value="134"/>
                    <measurement group_id="B7" value="159"/>
                    <measurement group_id="B8" value="151"/>
                    <measurement group_id="B9" value="158"/>
                    <measurement group_id="B10" value="111"/>
                    <measurement group_id="B11" value="116"/>
                    <measurement group_id="B12" value="131"/>
                    <measurement group_id="B13" value="33"/>
                    <measurement group_id="B14" value="39"/>
                    <measurement group_id="B15" value="36"/>
                    <measurement group_id="B16" value="8"/>
                    <measurement group_id="B17" value="9"/>
                    <measurement group_id="B18" value="5"/>
                    <measurement group_id="B19" value="1406"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="0"/>
                    <measurement group_id="B14" value="0"/>
                    <measurement group_id="B15" value="0"/>
                    <measurement group_id="B16" value="0"/>
                    <measurement group_id="B17" value="0"/>
                    <measurement group_id="B18" value="0"/>
                    <measurement group_id="B19" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="25"/>
                    <measurement group_id="B5" value="30"/>
                    <measurement group_id="B6" value="29"/>
                    <measurement group_id="B7" value="47"/>
                    <measurement group_id="B8" value="43"/>
                    <measurement group_id="B9" value="40"/>
                    <measurement group_id="B10" value="49"/>
                    <measurement group_id="B11" value="46"/>
                    <measurement group_id="B12" value="34"/>
                    <measurement group_id="B13" value="7"/>
                    <measurement group_id="B14" value="8"/>
                    <measurement group_id="B15" value="8"/>
                    <measurement group_id="B16" value="1"/>
                    <measurement group_id="B17" value="1"/>
                    <measurement group_id="B18" value="3"/>
                    <measurement group_id="B19" value="378"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Based on Seronegative mFAS</title>
        <description>Time-weighted average daily change from Day 1 to Day 7 in viral load (log10 copies/mL), as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.</description>
        <time_frame>Day 1 to Day 7</time_frame>
        <population>The seronegative modified full analysis set (mFAS) was defined as all participants in mFAS with documented seronegative status at the baseline. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O2">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O3">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O4">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
        </group_list>
        <measure>
          <title>Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Based on Seronegative mFAS</title>
          <description>Time-weighted average daily change from Day 1 to Day 7 in viral load (log10 copies/mL), as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.</description>
          <population>The seronegative modified full analysis set (mFAS) was defined as all participants in mFAS with documented seronegative status at the baseline. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
          <units>log10 copies/milliliter (mL)</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
                <count group_id="O2" value="150"/>
                <count group_id="O3" value="160"/>
                <count group_id="O4" value="310"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.03" spread="0.10"/>
                    <measurement group_id="O2" value="-1.28" spread="0.09"/>
                    <measurement group_id="O3" value="-1.34" spread="0.09"/>
                    <measurement group_id="O4" value="-1.31" spread="0.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0663</p_value>
            <p_value_desc>P-value for change from baseline on log scale for each treatment group was based on the Analysis of covariance (ANCOVA) model with treatment group.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Least Square (LS) Mean Difference</param_type>
            <param_value>-0.25</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.51</ci_lower_limit>
            <ci_upper_limit>0.02</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0204</p_value>
            <p_value_desc>P-value for change from baseline on log scale for each treatment group was based on the Analysis of covariance (ANCOVA) model with treatment group.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Least Square (LS) Mean Difference</param_type>
            <param_value>-0.31</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-0.57</ci_lower_limit>
            <ci_upper_limit>0.05</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0172</p_value>
            <p_value_desc>P-value for change from baseline on log scale for each treatment group was based on the Analysis of covariance (ANCOVA) model with treatment group.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Least Square (LS) Mean Difference</param_type>
            <param_value>-0.28</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.51</ci_lower_limit>
            <ci_upper_limit>-0.05</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on High Viral Load mFAS</title>
        <description>Percentage of participants who died or went on mechanical ventilation from Day 6 through Day 29 based on high viral load mFAS were reported.</description>
        <time_frame>Day 6 to Day 29</time_frame>
        <population>The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (&gt;) 10^6 copies per milliliter (mL). Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O2">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O3">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O4">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
        </group_list>
        <measure>
          <title>Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on High Viral Load mFAS</title>
          <description>Percentage of participants who died or went on mechanical ventilation from Day 6 through Day 29 based on high viral load mFAS were reported.</description>
          <population>The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (&gt;) 10^6 copies per milliliter (mL). Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="211"/>
                <count group_id="O2" value="220"/>
                <count group_id="O3" value="225"/>
                <count group_id="O4" value="445"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.3" lower_limit="9.0" upper_limit="18.6"/>
                    <measurement group_id="O2" value="7.3" lower_limit="4.2" upper_limit="11.5"/>
                    <measurement group_id="O3" value="12.4" lower_limit="8.4" upper_limit="17.5"/>
                    <measurement group_id="O4" value="9.9" lower_limit="7.3" upper_limit="13.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0431</p_value>
            <p_value_desc>P-value was derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value was based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7975</p_value>
            <p_value_desc>P-value was derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value was based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2048</p_value>
            <p_value_desc>P-value was derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value was based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on Seronegative mFAS</title>
        <description>Percentage of participants who died or went on mechanical ventilation from Day 6 through Day 29 based on seronegative mFAS were reported.</description>
        <time_frame>Day 6 to Day 29</time_frame>
        <population>The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O2">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O3">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O4">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
        </group_list>
        <measure>
          <title>Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on Seronegative mFAS</title>
          <description>Percentage of participants who died or went on mechanical ventilation from Day 6 through Day 29 based on seronegative mFAS were reported.</description>
          <population>The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="147"/>
                <count group_id="O2" value="162"/>
                <count group_id="O3" value="179"/>
                <count group_id="O4" value="341"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.0" lower_limit="9.6" upper_limit="21.8"/>
                    <measurement group_id="O2" value="4.9" lower_limit="2.2" upper_limit="9.5"/>
                    <measurement group_id="O3" value="10.6" lower_limit="6.5" upper_limit="16.1"/>
                    <measurement group_id="O4" value="7.9" lower_limit="5.3" upper_limit="11.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0039</p_value>
            <p_value_desc>P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value was based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2415</p_value>
            <p_value_desc>P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value was based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0195</p_value>
            <p_value_desc>P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value was based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on Overall mFAS</title>
        <description>Percentage of participants who died or went on mechanical ventilation from Day 6 through Day 29 based on overall FAS were reported.</description>
        <time_frame>Day 6 to Day 29</time_frame>
        <population>The mFAS included all FAS participants with a positive SARS-CoV-2 RT-qPCR conducted in the central laboratory in NP swab samples at randomization. Analysis based on treatment allocated (as randomized). &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O2">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O3">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O4">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
        </group_list>
        <measure>
          <title>Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on Overall mFAS</title>
          <description>Percentage of participants who died or went on mechanical ventilation from Day 6 through Day 29 based on overall FAS were reported.</description>
          <population>The mFAS included all FAS participants with a positive SARS-CoV-2 RT-qPCR conducted in the central laboratory in NP swab samples at randomization. Analysis based on treatment allocated (as randomized). &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="367"/>
                <count group_id="O2" value="387"/>
                <count group_id="O3" value="383"/>
                <count group_id="O4" value="770"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.6" lower_limit="7.7" upper_limit="14.2"/>
                    <measurement group_id="O2" value="5.4" lower_limit="3.4" upper_limit="8.2"/>
                    <measurement group_id="O3" value="10.7" lower_limit="7.8" upper_limit="14.2"/>
                    <measurement group_id="O4" value="8.1" lower_limit="6.2" upper_limit="10.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0085</p_value>
            <p_value_desc>P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; = 5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9902</p_value>
            <p_value_desc>P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; = 5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1486</p_value>
            <p_value_desc>P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; = 5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on High Viral Load mFAS</title>
        <description>Percentage of participants who died or went on mechanical ventilation from Day 1 through Day 29 based on high viral load mFAS were reported.</description>
        <time_frame>Day 1 to Day 29</time_frame>
        <population>The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load &gt; 10^6 copies per mL. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O2">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O3">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O4">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
        </group_list>
        <measure>
          <title>Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on High Viral Load mFAS</title>
          <description>Percentage of participants who died or went on mechanical ventilation from Day 1 through Day 29 based on high viral load mFAS were reported.</description>
          <population>The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load &gt; 10^6 copies per mL. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="229"/>
                <count group_id="O2" value="231"/>
                <count group_id="O3" value="236"/>
                <count group_id="O4" value="467"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.8" lower_limit="13.9" upper_limit="24.4"/>
                    <measurement group_id="O2" value="10.0" lower_limit="6.4" upper_limit="14.6"/>
                    <measurement group_id="O3" value="14.4" lower_limit="10.2" upper_limit="19.5"/>
                    <measurement group_id="O4" value="12.2" lower_limit="9.4" upper_limit="15.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0092</p_value>
            <p_value_desc>P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; = 5 or n(1-p) &lt;= 5 in any treatment group, p-value was based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2210</p_value>
            <p_value_desc>P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; = 5 or n(1-p) &lt;= 5 in any treatment group, p-value was based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0249</p_value>
            <p_value_desc>P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; = 5 or n(1-p) &lt;= 5 in any treatment group, p-value was based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on Seronegative mFAS</title>
        <description>Percentage of participants who died or went on mechanical ventilation from Day 1 through Day 29 based on seronegative mFAS were reported.</description>
        <time_frame>Day 1 to Day 29</time_frame>
        <population>The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O2">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O3">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O4">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
        </group_list>
        <measure>
          <title>Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on Seronegative mFAS</title>
          <description>Percentage of participants who died or went on mechanical ventilation from Day 1 through Day 29 based on seronegative mFAS were reported.</description>
          <population>The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="160"/>
                <count group_id="O2" value="172"/>
                <count group_id="O3" value="188"/>
                <count group_id="O4" value="360"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.4" lower_limit="13.6" upper_limit="26.4"/>
                    <measurement group_id="O2" value="8.1" lower_limit="4.5" upper_limit="13.3"/>
                    <measurement group_id="O3" value="12.2" lower_limit="7.9" upper_limit="17.8"/>
                    <measurement group_id="O4" value="10.3" lower_limit="7.3" upper_limit="13.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0045</p_value>
            <p_value_desc>P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; = 5 or n(1-p) &lt;= 5 in any treatment group, p-value was based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0714</p_value>
            <p_value_desc>P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; = 5 or n(1-p) &lt;= 5 in any treatment group, p-value was based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0061</p_value>
            <p_value_desc>P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; = 5 or n(1-p) &lt;= 5 in any treatment group, p-value was based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on Overall mFAS</title>
        <description>Percentage of participants who died or went on mechanical ventilation from Day 1 through Day 29 based on overall mFAS were reported.</description>
        <time_frame>Day 1 to Day 29</time_frame>
        <population>The mFAS included all FAS participants with a positive SARS-CoV-2 RT-qPCR conducted in the central laboratory in NP swab samples at randomization. Analysis based on treatment allocated (as randomized). &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O2">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O3">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O4">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
        </group_list>
        <measure>
          <title>Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on Overall mFAS</title>
          <description>Percentage of participants who died or went on mechanical ventilation from Day 1 through Day 29 based on overall mFAS were reported.</description>
          <population>The mFAS included all FAS participants with a positive SARS-CoV-2 RT-qPCR conducted in the central laboratory in NP swab samples at randomization. Analysis based on treatment allocated (as randomized). &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="393"/>
                <count group_id="O2" value="406"/>
                <count group_id="O3" value="398"/>
                <count group_id="O4" value="804"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.8" lower_limit="11.4" upper_limit="18.7"/>
                    <measurement group_id="O2" value="7.9" lower_limit="5.5" upper_limit="10.9"/>
                    <measurement group_id="O3" value="12.6" lower_limit="9.5" upper_limit="16.2"/>
                    <measurement group_id="O4" value="10.2" lower_limit="8.2" upper_limit="12.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0023</p_value>
            <p_value_desc>P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; = 5 or n(1-p) &lt;= 5 in any treatment group, p-value was based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3544</p_value>
            <p_value_desc>P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; = 5 or n(1-p) &lt;= 5 in any treatment group, p-value was based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0212</p_value>
            <p_value_desc>P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; = 5 or n(1-p) &lt;= 5 in any treatment group, p-value was based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Treatment-Emergent Serious Adverse Events</title>
        <description>Treatment-emergent adverse events are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the observation period.</description>
        <time_frame>Up to Day 169</time_frame>
        <population>The mFAS included all FAS participants with a positive SARS-CoV-2 RT-qPCR conducted in the central laboratory in NP swab samples at randomization. Analysis based on treatment allocated (as randomized). &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Placebo</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching R10933+R10987 intravenously on Day 1</description>
          </group>
          <group group_id="O2">
            <title>Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (2400 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1</description>
          </group>
          <group group_id="O3">
            <title>Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1</description>
          </group>
          <group group_id="O4">
            <title>Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Treatment-Emergent Serious Adverse Events</title>
          <description>Treatment-emergent adverse events are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the observation period.</description>
          <population>The mFAS included all FAS participants with a positive SARS-CoV-2 RT-qPCR conducted in the central laboratory in NP swab samples at randomization. Analysis based on treatment allocated (as randomized). &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="222"/>
                <count group_id="O2" value="224"/>
                <count group_id="O3" value="225"/>
                <count group_id="O4" value="449"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54"/>
                    <measurement group_id="O2" value="45"/>
                    <measurement group_id="O3" value="47"/>
                    <measurement group_id="O4" value="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Grade &gt;=2 Infusion Related Reactions up to Day 4</title>
        <description>Infusion-related reactions are defined as any relevant adverse event that occurs during the infusion or up to day 4. The severity of adverse events (including test findings classified as adverse events) were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).</description>
        <time_frame>Up to Day 4</time_frame>
        <population>The mFAS included all FAS participants with a positive SARS-CoV-2 RT-qPCR conducted in the central laboratory in NP swab samples at randomization. Analysis based on treatment allocated (as randomized). &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Placebo</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching R10933+R10987 intravenously on Day 1</description>
          </group>
          <group group_id="O2">
            <title>Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (2400 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1</description>
          </group>
          <group group_id="O3">
            <title>Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1</description>
          </group>
          <group group_id="O4">
            <title>Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Grade &gt;=2 Infusion Related Reactions up to Day 4</title>
          <description>Infusion-related reactions are defined as any relevant adverse event that occurs during the infusion or up to day 4. The severity of adverse events (including test findings classified as adverse events) were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).</description>
          <population>The mFAS included all FAS participants with a positive SARS-CoV-2 RT-qPCR conducted in the central laboratory in NP swab samples at randomization. Analysis based on treatment allocated (as randomized). &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="222"/>
                <count group_id="O2" value="224"/>
                <count group_id="O3" value="225"/>
                <count group_id="O4" value="449"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Grade &gt;=2 Hypersensitivity Reactions Up to Day 29</title>
        <description>Hypersensitivity reactions are defined as any relevant adverse event that occurs during the infusion or up to study day 29. The severity of adverse events (including test findings classified as adverse events) were graded according to NCI-CTCAE.</description>
        <time_frame>Up to Day 29</time_frame>
        <population>The mFAS included all FAS participants with a positive SARS-CoV-2 RT-qPCR conducted in the central laboratory in NP swab samples at randomization. Analysis based on treatment allocated (as randomized). &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Placebo</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching R10933+R10987 intravenously on Day 1</description>
          </group>
          <group group_id="O2">
            <title>Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (2400 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1</description>
          </group>
          <group group_id="O3">
            <title>Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1</description>
          </group>
          <group group_id="O4">
            <title>Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Grade &gt;=2 Hypersensitivity Reactions Up to Day 29</title>
          <description>Hypersensitivity reactions are defined as any relevant adverse event that occurs during the infusion or up to study day 29. The severity of adverse events (including test findings classified as adverse events) were graded according to NCI-CTCAE.</description>
          <population>The mFAS included all FAS participants with a positive SARS-CoV-2 RT-qPCR conducted in the central laboratory in NP swab samples at randomization. Analysis based on treatment allocated (as randomized). &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="222"/>
                <count group_id="O2" value="224"/>
                <count group_id="O3" value="225"/>
                <count group_id="O4" value="449"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Cumulative Incidence of Death or Mechanical Ventilation Based on Seronegative mFAS</title>
        <description>Cumulative incidence percentage was estimated using Kaplan-Meier method.</description>
        <time_frame>Up to Day 29</time_frame>
        <population>Seronegative modified full analysis set (mFAS) was defined as all participants in mFAS with documented seronegative status at the baseline. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 1 [Cohort 1] and Phase 2 [Cohort 1].</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Placebo</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching R10933+R10987 intravenously on Day 1</description>
          </group>
          <group group_id="O2">
            <title>Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (2400 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1</description>
          </group>
          <group group_id="O3">
            <title>Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1</description>
          </group>
          <group group_id="O4">
            <title>Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Cumulative Incidence of Death or Mechanical Ventilation Based on Seronegative mFAS</title>
          <description>Cumulative incidence percentage was estimated using Kaplan-Meier method.</description>
          <population>Seronegative modified full analysis set (mFAS) was defined as all participants in mFAS with documented seronegative status at the baseline. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 1 [Cohort 1] and Phase 2 [Cohort 1].</population>
          <units>Cumulative Incidence Percentage</units>
          <param>Number</param>
          <dispersion>80% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="46"/>
                <count group_id="O3" value="41"/>
                <count group_id="O4" value="87"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.0" lower_limit="16.9" upper_limit="30.9"/>
                    <measurement group_id="O2" value="15.1" lower_limit="10.5" upper_limit="21.4"/>
                    <measurement group_id="O3" value="20.3" lower_limit="14.7" upper_limit="27.8"/>
                    <measurement group_id="O4" value="17.6" lower_limit="13.8" upper_limit="22.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Cumulative Incidence of Death or Mechanical Ventilation Based on High Viral Load mFAS</title>
        <description>Cumulative incidence percentage was estimated using Kaplan-Meier method.</description>
        <time_frame>Up to Day 29</time_frame>
        <population>High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (&gt;) 10^6 copies per milliliter (mL). As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 1 [Cohort 1] and Phase 2 [Cohort 1].</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Placebo</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching R10933+R10987 intravenously on Day 1</description>
          </group>
          <group group_id="O2">
            <title>Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (2400 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1</description>
          </group>
          <group group_id="O3">
            <title>Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1</description>
          </group>
          <group group_id="O4">
            <title>Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Cumulative Incidence of Death or Mechanical Ventilation Based on High Viral Load mFAS</title>
          <description>Cumulative incidence percentage was estimated using Kaplan-Meier method.</description>
          <population>High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (&gt;) 10^6 copies per milliliter (mL). As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 1 [Cohort 1] and Phase 2 [Cohort 1].</population>
          <units>Cumulative Incidence Percentage</units>
          <param>Number</param>
          <dispersion>80% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="53"/>
                <count group_id="O3" value="58"/>
                <count group_id="O4" value="111"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.7" lower_limit="15.7" upper_limit="26.9"/>
                    <measurement group_id="O2" value="18.9" lower_limit="14.3" upper_limit="24.8"/>
                    <measurement group_id="O3" value="11.6" lower_limit="8.0" upper_limit="16.8"/>
                    <measurement group_id="O4" value="15.3" lower_limit="12.2" upper_limit="19.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on High Viral Load mFAS</title>
        <description>Percentage of participants who went on mechanical ventilation by Day 29 based on High Viral Load mFAS in pooled analysis phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.</description>
        <time_frame>by Day 29</time_frame>
        <population>The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load &gt; 10^6 copies per mL. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O2">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O3">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O4">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
        </group_list>
        <measure>
          <title>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on High Viral Load mFAS</title>
          <description>Percentage of participants who went on mechanical ventilation by Day 29 based on High Viral Load mFAS in pooled analysis phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.</description>
          <population>The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load &gt; 10^6 copies per mL. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="229"/>
                <count group_id="O2" value="231"/>
                <count group_id="O3" value="236"/>
                <count group_id="O4" value="467"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.4" lower_limit="7.6" upper_limit="16.2"/>
                    <measurement group_id="O2" value="6.1" lower_limit="3.4" upper_limit="10.0"/>
                    <measurement group_id="O3" value="8.5" lower_limit="5.3" upper_limit="12.8"/>
                    <measurement group_id="O4" value="7.3" lower_limit="5.1" upper_limit="10.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0575</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3133</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0849</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on Seronegative mFAS</title>
        <description>Percentage of participants who went on mechanical ventilation at Day 29 based on Seronegative mFAS in pooled analysis phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.</description>
        <time_frame>by Day 29</time_frame>
        <population>The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O2">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O3">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O4">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
        </group_list>
        <measure>
          <title>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on Seronegative mFAS</title>
          <description>Percentage of participants who went on mechanical ventilation at Day 29 based on Seronegative mFAS in pooled analysis phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.</description>
          <population>The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="160"/>
                <count group_id="O2" value="172"/>
                <count group_id="O3" value="188"/>
                <count group_id="O4" value="360"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.0" lower_limit="5.8" upper_limit="15.7"/>
                    <measurement group_id="O2" value="5.8" lower_limit="2.8" upper_limit="10.4"/>
                    <measurement group_id="O3" value="7.4" lower_limit="4.1" upper_limit="12.2"/>
                    <measurement group_id="O4" value="6.7" lower_limit="4.3" upper_limit="9.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2167</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4123</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2206</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on High Viral Load mFAS</title>
        <description>Percentage of participants who died from Day 6 through Day 29 based on high viral load mFAS were reported.</description>
        <time_frame>Day 6 to Day 29</time_frame>
        <population>The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load &gt; 10^6 copies per mL. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O2">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O3">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O4">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
        </group_list>
        <measure>
          <title>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on High Viral Load mFAS</title>
          <description>Percentage of participants who died from Day 6 through Day 29 based on high viral load mFAS were reported.</description>
          <population>The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load &gt; 10^6 copies per mL. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="222"/>
                <count group_id="O2" value="226"/>
                <count group_id="O3" value="228"/>
                <count group_id="O4" value="454"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.1" lower_limit="8.9" upper_limit="18.2"/>
                    <measurement group_id="O2" value="7.1" lower_limit="4.1" upper_limit="11.2"/>
                    <measurement group_id="O3" value="10.1" lower_limit="6.5" upper_limit="14.8"/>
                    <measurement group_id="O4" value="8.6" lower_limit="6.2" upper_limit="11.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0383</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3296</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0766</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on Seronegative mFAS</title>
        <description>Percentage of participants who died from Day 6 through Day 29 Based on seronegative mFAS in pooled analysis phase 3 (cohort 1) and phase 2 (cohort 1A) were reported.</description>
        <time_frame>Day 6 to Day 29</time_frame>
        <population>The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O2">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O3">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O4">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
        </group_list>
        <measure>
          <title>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on Seronegative mFAS</title>
          <description>Percentage of participants who died from Day 6 through Day 29 Based on seronegative mFAS in pooled analysis phase 3 (cohort 1) and phase 2 (cohort 1A) were reported.</description>
          <population>The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="153"/>
                <count group_id="O2" value="167"/>
                <count group_id="O3" value="181"/>
                <count group_id="O4" value="348"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.7" lower_limit="8.7" upper_limit="20.2"/>
                    <measurement group_id="O2" value="4.8" lower_limit="2.1" upper_limit="9.2"/>
                    <measurement group_id="O3" value="7.2" lower_limit="3.9" upper_limit="12.0"/>
                    <measurement group_id="O4" value="6.0" lower_limit="3.8" upper_limit="9.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0070</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0507</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0051</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on High Viral Load mFAS</title>
        <description>Percentage of participants who died from Day 1 through Day 29 based on High Viral Load mFAS in pooled analysis phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported.</description>
        <time_frame>Day 1 to Day 29</time_frame>
        <population>The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load &gt; 10^6 copies per mL. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O2">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O3">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O4">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
        </group_list>
        <measure>
          <title>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on High Viral Load mFAS</title>
          <description>Percentage of participants who died from Day 1 through Day 29 based on High Viral Load mFAS in pooled analysis phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported.</description>
          <population>The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load &gt; 10^6 copies per mL. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="229"/>
                <count group_id="O2" value="231"/>
                <count group_id="O3" value="236"/>
                <count group_id="O4" value="467"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.4" lower_limit="10.1" upper_limit="19.6"/>
                    <measurement group_id="O2" value="7.4" lower_limit="4.3" upper_limit="11.5"/>
                    <measurement group_id="O3" value="11.0" lower_limit="7.3" upper_limit="15.7"/>
                    <measurement group_id="O4" value="9.2" lower_limit="6.7" upper_limit="12.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0174</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2900</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0454</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on Seronegative mFAS</title>
        <description>Percentage of participants who died from Day 1 through Day 29 based on seronegative mFAS in pooled analysis phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported.</description>
        <time_frame>Day 1 to Day 29</time_frame>
        <population>The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O2">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O3">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O4">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
        </group_list>
        <measure>
          <title>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on Seronegative mFAS</title>
          <description>Percentage of participants who died from Day 1 through Day 29 based on seronegative mFAS in pooled analysis phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported.</description>
          <population>The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="160"/>
                <count group_id="O2" value="172"/>
                <count group_id="O3" value="188"/>
                <count group_id="O4" value="360"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.0" lower_limit="9.9" upper_limit="21.5"/>
                    <measurement group_id="O2" value="5.2" lower_limit="2.4" upper_limit="9.7"/>
                    <measurement group_id="O3" value="8.0" lower_limit="4.5" upper_limit="12.8"/>
                    <measurement group_id="O4" value="6.7" lower_limit="4.3" upper_limit="9.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0040</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0413</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0032</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on High Viral Load mFAS</title>
        <description>Percentage of participants who were discharged by Day 29 based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported.</description>
        <time_frame>by Day 29</time_frame>
        <population>The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load &gt; 10^6 copies per mL. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O2">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O3">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O4">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
        </group_list>
        <measure>
          <title>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on High Viral Load mFAS</title>
          <description>Percentage of participants who were discharged by Day 29 based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported.</description>
          <population>The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load &gt; 10^6 copies per mL. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="229"/>
                <count group_id="O2" value="231"/>
                <count group_id="O3" value="236"/>
                <count group_id="O4" value="467"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.3" lower_limit="74.6" upper_limit="85.3"/>
                    <measurement group_id="O2" value="89.2" lower_limit="84.4" upper_limit="92.9"/>
                    <measurement group_id="O3" value="86.9" lower_limit="81.9" upper_limit="90.9"/>
                    <measurement group_id="O4" value="88.0" lower_limit="84.7" upper_limit="90.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0105</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0622</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0088</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on Seronegative mFAS</title>
        <description>Percentage of participants who were discharged by Day 29 based on seronegative mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported.</description>
        <time_frame>by Day 29</time_frame>
        <population>The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O2">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O3">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O4">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
        </group_list>
        <measure>
          <title>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on Seronegative mFAS</title>
          <description>Percentage of participants who were discharged by Day 29 based on seronegative mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported.</description>
          <population>The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="160"/>
                <count group_id="O2" value="172"/>
                <count group_id="O3" value="188"/>
                <count group_id="O4" value="360"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.3" lower_limit="74.3" upper_limit="87.0"/>
                    <measurement group_id="O2" value="90.1" lower_limit="84.6" upper_limit="94.1"/>
                    <measurement group_id="O3" value="89.9" lower_limit="84.7" upper_limit="93.8"/>
                    <measurement group_id="O4" value="90.0" lower_limit="86.4" upper_limit="92.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0275</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0223</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0072</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital Over Time Based on High Viral Load mFAS</title>
        <description>Percentage of participants who died or were readmitted to hospital over time based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A)were reported. Readmission to hospital was based on investigator report.</description>
        <time_frame>Up to Day 29</time_frame>
        <population>The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load &gt; 10^6 copies per mL. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O2">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O3">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O4">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
        </group_list>
        <measure>
          <title>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital Over Time Based on High Viral Load mFAS</title>
          <description>Percentage of participants who died or were readmitted to hospital over time based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A)were reported. Readmission to hospital was based on investigator report.</description>
          <population>The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load &gt; 10^6 copies per mL. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="229"/>
                <count group_id="O2" value="231"/>
                <count group_id="O3" value="236"/>
                <count group_id="O4" value="467"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.0" lower_limit="15.9" upper_limit="26.8"/>
                    <measurement group_id="O2" value="15.2" lower_limit="10.8" upper_limit="20.4"/>
                    <measurement group_id="O3" value="17.4" lower_limit="12.8" upper_limit="22.8"/>
                    <measurement group_id="O4" value="16.3" lower_limit="13.0" upper_limit="19.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1032</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3350</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1314</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital by Day 29 Based on Seronegative mFAS</title>
        <description>Percentage of participants who died or were readmitted to hospital at Day 29 based on seronegative mFAS in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Readmission to hospital was based on investigator report.</description>
        <time_frame>by Day 29</time_frame>
        <population>The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O2">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O3">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O4">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
        </group_list>
        <measure>
          <title>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital by Day 29 Based on Seronegative mFAS</title>
          <description>Percentage of participants who died or were readmitted to hospital at Day 29 based on seronegative mFAS in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Readmission to hospital was based on investigator report.</description>
          <population>The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="160"/>
                <count group_id="O2" value="172"/>
                <count group_id="O3" value="188"/>
                <count group_id="O4" value="360"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.4" lower_limit="17.9" upper_limit="31.8"/>
                    <measurement group_id="O2" value="11.6" lower_limit="7.2" upper_limit="17.4"/>
                    <measurement group_id="O3" value="12.8" lower_limit="8.4" upper_limit="18.4"/>
                    <measurement group_id="O4" value="12.2" lower_limit="9.0" upper_limit="16.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.00024</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0054</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0005</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death (ie, Overall Survival) by Day 29 Based on High Viral Load mFAS</title>
        <description>Overall Survival was defined as time interval from randomization to death. Percentage of participants with cumulative incidence of death (ie, overall survival) at Day 29 from randomization based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.</description>
        <time_frame>by Day 29</time_frame>
        <population>The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load &gt; 10^6 copies per mL. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O2">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O3">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O4">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
        </group_list>
        <measure>
          <title>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death (ie, Overall Survival) by Day 29 Based on High Viral Load mFAS</title>
          <description>Overall Survival was defined as time interval from randomization to death. Percentage of participants with cumulative incidence of death (ie, overall survival) at Day 29 from randomization based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.</description>
          <population>The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load &gt; 10^6 copies per mL. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
          <units>Cumulative Incidence Percentage</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="181"/>
                <count group_id="O2" value="201"/>
                <count group_id="O3" value="190"/>
                <count group_id="O4" value="391"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.9" lower_limit="10.8" upper_limit="20.3"/>
                    <measurement group_id="O2" value="7.7" lower_limit="4.8" upper_limit="12.1"/>
                    <measurement group_id="O3" value="11.7" lower_limit="8.1" upper_limit="16.7"/>
                    <measurement group_id="O4" value="9.7" lower_limit="7.3" upper_limit="12.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death (ie, Overall Survival) by Day 29 Based on Seronegative mFAS</title>
        <description>Overall Survival was defined as time interval from randomization to death. Percentage of participants with cumulative incidence of death (ie, overall survival) at Day 29 from randomization based on seronegative mFAS in phase 3 (Cohort 1) and phase 2 (Cohort 1A)were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.</description>
        <time_frame>by Day 29</time_frame>
        <population>The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O2">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O3">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O4">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
        </group_list>
        <measure>
          <title>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death (ie, Overall Survival) by Day 29 Based on Seronegative mFAS</title>
          <description>Overall Survival was defined as time interval from randomization to death. Percentage of participants with cumulative incidence of death (ie, overall survival) at Day 29 from randomization based on seronegative mFAS in phase 3 (Cohort 1) and phase 2 (Cohort 1A)were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.</description>
          <population>The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
          <units>Cumulative Incidence Percentage</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="121"/>
                <count group_id="O2" value="148"/>
                <count group_id="O3" value="160"/>
                <count group_id="O4" value="308"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.8" lower_limit="10.9" upper_limit="22.7"/>
                    <measurement group_id="O2" value="5.6" lower_limit="3.0" upper_limit="10.5"/>
                    <measurement group_id="O3" value="8.4" lower_limit="5.1" upper_limit="13.5"/>
                    <measurement group_id="O4" value="7.0" lower_limit="4.8" upper_limit="10.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on High Viral Load mFAS</title>
        <description>Number of participants with cumulative incidence of mechanical ventilation by Day 29 based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.</description>
        <time_frame>by Day 29</time_frame>
        <population>The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load &gt; 10^6 copies per mL. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O2">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O3">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O4">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
        </group_list>
        <measure>
          <title>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on High Viral Load mFAS</title>
          <description>Number of participants with cumulative incidence of mechanical ventilation by Day 29 based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.</description>
          <population>The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load &gt; 10^6 copies per mL. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
          <units>Cumulative Incidence Percentage</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="170"/>
                <count group_id="O2" value="194"/>
                <count group_id="O3" value="183"/>
                <count group_id="O4" value="377"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.8" lower_limit="8.2" upper_limit="16.8"/>
                    <measurement group_id="O2" value="6.3" lower_limit="3.7" upper_limit="10.3"/>
                    <measurement group_id="O3" value="9.1" lower_limit="6.0" upper_limit="13.8"/>
                    <measurement group_id="O4" value="7.7" lower_limit="5.5" upper_limit="10.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on Seronegative mFAS</title>
        <description>Percentage of participants with cumulative incidence of mechanical ventilation by Day 29 based on seronegative mFAS in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.</description>
        <time_frame>by Day 29</time_frame>
        <population>The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O2">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O3">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O4">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
        </group_list>
        <measure>
          <title>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on Seronegative mFAS</title>
          <description>Percentage of participants with cumulative incidence of mechanical ventilation by Day 29 based on seronegative mFAS in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.</description>
          <population>The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
          <units>Cumulative Incidence Percentage</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="114"/>
                <count group_id="O2" value="143"/>
                <count group_id="O3" value="152"/>
                <count group_id="O4" value="295"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.6" lower_limit="6.6" upper_limit="16.8"/>
                    <measurement group_id="O2" value="6.0" lower_limit="3.3" upper_limit="11.0"/>
                    <measurement group_id="O3" value="7.9" lower_limit="4.8" upper_limit="13.0"/>
                    <measurement group_id="O4" value="7.0" lower_limit="4.8" upper_limit="10.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on High Viral Load mFAS</title>
        <description>Percentage of participants with cumulative incidence of death or mechanical ventilation by Day 29 based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.</description>
        <time_frame>by Day 29</time_frame>
        <population>The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load &gt; 10^6 copies per mL. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O2">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O3">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O4">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
        </group_list>
        <measure>
          <title>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on High Viral Load mFAS</title>
          <description>Percentage of participants with cumulative incidence of death or mechanical ventilation by Day 29 based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.</description>
          <population>The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load &gt; 10^6 copies per mL. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
          <units>Cumulative Incidence Percentage</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="170"/>
                <count group_id="O2" value="194"/>
                <count group_id="O3" value="183"/>
                <count group_id="O4" value="377"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.1" lower_limit="14.6" upper_limit="24.9"/>
                    <measurement group_id="O2" value="10.2" lower_limit="6.9" upper_limit="15.0"/>
                    <measurement group_id="O3" value="15.0" lower_limit="11.0" upper_limit="20.4"/>
                    <measurement group_id="O4" value="12.7" lower_limit="9.9" upper_limit="16.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on Seronegative mFAS</title>
        <description>Percentage of participants with cumulative incidence of death or mechanical ventilation by Day 29 based on seronegative mFAS in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.</description>
        <time_frame>by Day 29</time_frame>
        <population>The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O2">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O3">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O4">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
        </group_list>
        <measure>
          <title>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on Seronegative mFAS</title>
          <description>Percentage of participants with cumulative incidence of death or mechanical ventilation by Day 29 based on seronegative mFAS in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.</description>
          <population>The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
          <units>Cumulative Incidence Percentage</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="114"/>
                <count group_id="O2" value="143"/>
                <count group_id="O3" value="152"/>
                <count group_id="O4" value="295"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.1" lower_limit="14.6" upper_limit="27.3"/>
                    <measurement group_id="O2" value="8.4" lower_limit="5.1" upper_limit="13.8"/>
                    <measurement group_id="O3" value="12.7" lower_limit="8.7" upper_limit="18.6"/>
                    <measurement group_id="O4" value="10.7" lower_limit="7.9" upper_limit="14.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on High Viral Load mFAS</title>
        <description>Time to discharge from hospital based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) was reported.</description>
        <time_frame>Up to Day 56</time_frame>
        <population>The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load &gt; 10^6 copies per mL. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O2">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O3">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O4">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
        </group_list>
        <measure>
          <title>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on High Viral Load mFAS</title>
          <description>Time to discharge from hospital based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) was reported.</description>
          <population>The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load &gt; 10^6 copies per mL. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="229"/>
                <count group_id="O2" value="231"/>
                <count group_id="O3" value="236"/>
                <count group_id="O4" value="467"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" lower_limit="4.0" upper_limit="6.0"/>
                    <measurement group_id="O2" value="4.0" lower_limit="4.0" upper_limit="5.0"/>
                    <measurement group_id="O3" value="4.0" lower_limit="3.0" upper_limit="5.0"/>
                    <measurement group_id="O4" value="4.0" lower_limit="4.0" upper_limit="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0533</p_value>
            <p_value_desc>P-value based on stratified log-rank test with the type of background standard-of-care and baseline serostatus as stratification factors.</p_value_desc>
            <method>Log Rank</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0411</p_value>
            <p_value_desc>P-value based on stratified log-rank test with the type of background standard-of-care and baseline serostatus as stratification factors.</p_value_desc>
            <method>Log Rank</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0229</p_value>
            <p_value_desc>P-value based on stratified log-rank test with the type of background standard-of-care and baseline serostatus as stratification factors.</p_value_desc>
            <method>Log Rank</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on Seronegative mFAS</title>
        <description>Time to discharge from hospital based on Seronegative mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) was reported.</description>
        <time_frame>Up to Day 56</time_frame>
        <population>The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Placebo</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O2">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (2400mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O3">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): R10933+R10987 (8000mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O4">
            <title>Pooled (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
        </group_list>
        <measure>
          <title>Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on Seronegative mFAS</title>
          <description>Time to discharge from hospital based on Seronegative mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) was reported.</description>
          <population>The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="160"/>
                <count group_id="O2" value="172"/>
                <count group_id="O3" value="188"/>
                <count group_id="O4" value="360"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" lower_limit="4.0" upper_limit="6.0"/>
                    <measurement group_id="O2" value="4.0" lower_limit="3.0" upper_limit="5.0"/>
                    <measurement group_id="O3" value="4.0" lower_limit="3.0" upper_limit="4.0"/>
                    <measurement group_id="O4" value="4.0" lower_limit="3.0" upper_limit="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0218</p_value>
            <method>Stratified Log Rank Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0156</p_value>
            <method>Stratified Log Rank Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0067</p_value>
            <method>Stratified Log Rank Test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants With Treatment-Emergent Serious Adverse Events</title>
        <time_frame>Up to Day 169</time_frame>
        <population>all FAS participants. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled Placebo</title>
            <description>Participants received single dose of placebo matching to R10933+R10987 intravenously on Day 1</description>
          </group>
          <group group_id="O2">
            <title>Pooled R10933+R10987 2400 mg IV</title>
            <description>Participants received a single dose of R10933+R10987 2400 mg intravenously on Day 1</description>
          </group>
          <group group_id="O3">
            <title>Pooled R10933+R10987 8000 mg IV</title>
            <description>Participants received a single dose of R10933+R10987 8000 mg intravenously on Day 1.</description>
          </group>
          <group group_id="O4">
            <title>Pooled Combined R10933+R10987 IV</title>
            <description>Participants received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants With Treatment-Emergent Serious Adverse Events</title>
          <population>all FAS participants. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="730"/>
                <count group_id="O2" value="740"/>
                <count group_id="O3" value="733"/>
                <count group_id="O4" value="1473"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="203"/>
                    <measurement group_id="O2" value="177"/>
                    <measurement group_id="O3" value="181"/>
                    <measurement group_id="O4" value="358"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants With Grade &gt;=2 Infusion Related Reactions up to Day 4</title>
        <time_frame>Up to Day 4</time_frame>
        <population>all FAS participants. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled Placebo</title>
            <description>Participants received single dose of placebo matching to R10933+R10987 intravenously on Day 1</description>
          </group>
          <group group_id="O2">
            <title>Pooled R10933+R10987 2400 mg IV</title>
            <description>Participants received a single dose of R10933+R10987 2400 mg intravenously on Day 1</description>
          </group>
          <group group_id="O3">
            <title>Pooled R10933+R10987 8000 mg IV</title>
            <description>Participants received a single dose of R10933+R10987 8000 mg intravenously on Day 1</description>
          </group>
          <group group_id="O4">
            <title>Pooled Combined R10933+R10987 IV</title>
            <description>Participants received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants With Grade &gt;=2 Infusion Related Reactions up to Day 4</title>
          <population>all FAS participants. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="730"/>
                <count group_id="O2" value="740"/>
                <count group_id="O3" value="733"/>
                <count group_id="O4" value="1473"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="15"/>
                    <measurement group_id="O4" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants With Grade &gt;=2 Hypersensitivity Reactions Up to Day 29</title>
        <time_frame>Up to Day 29</time_frame>
        <population>all FAS participants. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled Placebo</title>
            <description>Participants received single dose of placebo matching to R10933+R10987 intravenously on Day 1</description>
          </group>
          <group group_id="O2">
            <title>Pooled R10933+R10987 2400 mg IV</title>
            <description>Participants received a single dose of R10933+R10987 2400 mg intravenously on Day 1</description>
          </group>
          <group group_id="O3">
            <title>Pooled R10933+R10987 8000 mg IV</title>
            <description>Participants received a single dose of R10933+R10987 8000 mg intravenously on Day 1</description>
          </group>
          <group group_id="O4">
            <title>Pooled Combined R10933+R10987 IV</title>
            <description>Participants received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants With Grade &gt;=2 Hypersensitivity Reactions Up to Day 29</title>
          <population>all FAS participants. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="730"/>
                <count group_id="O2" value="740"/>
                <count group_id="O3" value="733"/>
                <count group_id="O4" value="1473"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on Seronegative mFAS</title>
        <description>Percentage of participants who went on mechanical ventilation in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.</description>
        <time_frame>by Day 29</time_frame>
        <population>The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 3: Cohort 1 (Placebo)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1</description>
          </group>
          <group group_id="O2">
            <title>Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O3">
            <title>Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O4">
            <title>Phase 3 (Cohort 1): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O5">
            <title>Phase 2: Cohort 1A (Placebo)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O6">
            <title>Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O7">
            <title>Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A</description>
          </group>
          <group group_id="O8">
            <title>Phase 2 (Cohort 1A): Combined R10933+R10987 IV</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000mg intravenously on Day 1 in Cohort 1A.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on Seronegative mFAS</title>
          <description>Percentage of participants who went on mechanical ventilation in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.</description>
          <population>The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="80"/>
                <count group_id="O3" value="82"/>
                <count group_id="O4" value="162"/>
                <count group_id="O5" value="90"/>
                <count group_id="O6" value="92"/>
                <count group_id="O7" value="106"/>
                <count group_id="O8" value="198"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.1" lower_limit="9.2" upper_limit="28.0"/>
                    <measurement group_id="O2" value="8.8" lower_limit="3.6" upper_limit="17.2"/>
                    <measurement group_id="O3" value="17.1" lower_limit="9.7" upper_limit="27.0"/>
                    <measurement group_id="O4" value="13.0" lower_limit="8.2" upper_limit="19.1"/>
                    <measurement group_id="O5" value="4.4" lower_limit="1.2" upper_limit="11.0"/>
                    <measurement group_id="O6" value="3.3" lower_limit="0.7" upper_limit="9.2"/>
                    <measurement group_id="O7" value="0.0" lower_limit="0.0" upper_limit="0.0"/>
                    <measurement group_id="O8" value="1.5" lower_limit="0.3" upper_limit="4.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2162</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8783</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5583</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7189</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0429</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2103</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on Seronegative mFAS</title>
        <description>Percentage of participants who died from Day 6 through Day 29 in phase 3 (cohort 1) and phase 2 (cohort 1A) were reported.</description>
        <time_frame>Day 6 to Day 29</time_frame>
        <population>The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 3: Cohort 1 (Placebo)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1</description>
          </group>
          <group group_id="O2">
            <title>Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O3">
            <title>Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O4">
            <title>Phase 3 (Cohort 1): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O5">
            <title>Phase 2: Cohort 1A (Placebo)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O6">
            <title>Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A</description>
          </group>
          <group group_id="O7">
            <title>Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O8">
            <title>Phase 2 (Cohort 1A): Combined R10933+R10987 IV</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on Seronegative mFAS</title>
          <description>Percentage of participants who died from Day 6 through Day 29 in phase 3 (cohort 1) and phase 2 (cohort 1A) were reported.</description>
          <population>The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="79"/>
                <count group_id="O3" value="80"/>
                <count group_id="O4" value="159"/>
                <count group_id="O5" value="86"/>
                <count group_id="O6" value="88"/>
                <count group_id="O7" value="101"/>
                <count group_id="O8" value="189"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.4" lower_limit="10.8" upper_limit="30.9"/>
                    <measurement group_id="O2" value="6.3" lower_limit="2.1" upper_limit="14.2"/>
                    <measurement group_id="O3" value="10.0" lower_limit="4.4" upper_limit="13.6"/>
                    <measurement group_id="O4" value="8.2" lower_limit="4.4" upper_limit="13.6"/>
                    <measurement group_id="O5" value="9.3" lower_limit="4.1" upper_limit="17.5"/>
                    <measurement group_id="O6" value="3.4" lower_limit="0.7" upper_limit="9.6"/>
                    <measurement group_id="O7" value="5.0" lower_limit="1.6" upper_limit="11.2"/>
                    <measurement group_id="O8" value="4.2" lower_limit="1.8" upper_limit="8.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0223</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1256</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0230</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1298</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2642</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0970</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on Seronegative mFAS</title>
        <description>Percentage of participants who died from Day 1 through Day 29 in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported.</description>
        <time_frame>Day 1 to Day 29</time_frame>
        <population>The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 3: Cohort 1 (Placebo)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1</description>
          </group>
          <group group_id="O2">
            <title>Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1</description>
          </group>
          <group group_id="O3">
            <title>Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1</description>
          </group>
          <group group_id="O4">
            <title>Phase 3 (Cohort 1): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O5">
            <title>Phase 2: Cohort 1A (Placebo)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O6">
            <title>Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O7">
            <title>Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A</description>
          </group>
          <group group_id="O8">
            <title>Phase 2 (Cohort 1A): Combined R10933+R10987 IV</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on Seronegative mFAS</title>
          <description>Percentage of participants who died from Day 1 through Day 29 in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported.</description>
          <population>The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="80"/>
                <count group_id="O3" value="82"/>
                <count group_id="O4" value="162"/>
                <count group_id="O5" value="90"/>
                <count group_id="O6" value="92"/>
                <count group_id="O7" value="106"/>
                <count group_id="O8" value="198"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.9" lower_limit="13.7" upper_limit="34.4"/>
                    <measurement group_id="O2" value="7.5" lower_limit="2.8" upper_limit="15.6"/>
                    <measurement group_id="O3" value="11.0" lower_limit="5.1" upper_limit="19.8"/>
                    <measurement group_id="O4" value="9.3" lower_limit="5.3" upper_limit="14.8"/>
                    <measurement group_id="O5" value="8.9" lower_limit="3.9" upper_limit="16.8"/>
                    <measurement group_id="O6" value="3.3" lower_limit="0.7" upper_limit="9.2"/>
                    <measurement group_id="O7" value="5.7" lower_limit="2.1" upper_limit="11.9"/>
                    <measurement group_id="O8" value="4.5" lower_limit="2.1" upper_limit="8.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0147</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0669</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0094</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1306</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3576</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1476</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on Seronegative mFAS</title>
        <description>Percentage of participants who were discharged in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) by Day 29 were reported.</description>
        <time_frame>by Day 29</time_frame>
        <population>The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 3: Cohort 1 (Placebo)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1</description>
          </group>
          <group group_id="O2">
            <title>Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O3">
            <title>Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O4">
            <title>Phase 3 (Cohort 1): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O5">
            <title>Phase 2: Cohort 1A (Placebo)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O6">
            <title>Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O7">
            <title>Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O8">
            <title>Phase 2 (Cohort 1A): Combined R10933+R10987 IV</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on Seronegative mFAS</title>
          <description>Percentage of participants who were discharged in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) by Day 29 were reported.</description>
          <population>The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="80"/>
                <count group_id="O3" value="82"/>
                <count group_id="O4" value="162"/>
                <count group_id="O5" value="90"/>
                <count group_id="O6" value="92"/>
                <count group_id="O7" value="106"/>
                <count group_id="O8" value="198"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.0" lower_limit="57.9" upper_limit="80.4"/>
                    <measurement group_id="O2" value="85.0" lower_limit="75.3" upper_limit="92.0"/>
                    <measurement group_id="O3" value="84.1" lower_limit="74.4" upper_limit="91.3"/>
                    <measurement group_id="O4" value="84.6" lower_limit="78.1" upper_limit="89.8"/>
                    <measurement group_id="O5" value="90.0" lower_limit="81.9" upper_limit="95.3"/>
                    <measurement group_id="O6" value="94.6" lower_limit="87.8" upper_limit="98.2"/>
                    <measurement group_id="O7" value="94.3" lower_limit="88.1" upper_limit="97.9"/>
                    <measurement group_id="O8" value="94.4" lower_limit="90.3" upper_limit="97.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0481</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0535</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0199</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2784</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2510</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1702</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital by Day 29 Based on Seronegative mFAS</title>
        <description>Percentage of participants who died or were readmitted to hospital in phase 3 (Cohort 1) and phase 2 (Cohort 1A) by Day 29 were reported. Readmission to hospital was based on investigator report.</description>
        <time_frame>Up to Day 29</time_frame>
        <population>The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 3: Cohort 1 (Placebo)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1</description>
          </group>
          <group group_id="O2">
            <title>Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O3">
            <title>Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1</description>
          </group>
          <group group_id="O4">
            <title>Phase 3 (Cohort 1): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O5">
            <title>Phase 2: Cohort 1A (Placebo)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O6">
            <title>Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A</description>
          </group>
          <group group_id="O7">
            <title>Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O8">
            <title>Phase 2 (Cohort 1A): Combined R10933+R10987 IV</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital by Day 29 Based on Seronegative mFAS</title>
          <description>Percentage of participants who died or were readmitted to hospital in phase 3 (Cohort 1) and phase 2 (Cohort 1A) by Day 29 were reported. Readmission to hospital was based on investigator report.</description>
          <population>The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="80"/>
                <count group_id="O3" value="82"/>
                <count group_id="O4" value="162"/>
                <count group_id="O5" value="90"/>
                <count group_id="O6" value="92"/>
                <count group_id="O7" value="106"/>
                <count group_id="O8" value="198"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.1" lower_limit="17.2" upper_limit="39.1"/>
                    <measurement group_id="O2" value="13.8" lower_limit="7.1" upper_limit="23.3"/>
                    <measurement group_id="O3" value="14.6" lower_limit="7.8" upper_limit="24.2"/>
                    <measurement group_id="O4" value="14.2" lower_limit="9.2" upper_limit="20.5"/>
                    <measurement group_id="O5" value="22.2" lower_limit="14.1" upper_limit="32.2"/>
                    <measurement group_id="O6" value="9.8" lower_limit="4.6" upper_limit="17.8"/>
                    <measurement group_id="O7" value="11.3" lower_limit="6.0" upper_limit="18.9"/>
                    <measurement group_id="O8" value="10.6" lower_limit="6.7" upper_limit="15.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0500</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0663</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0229</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0208</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0388</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0092</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death up to Day 29 Based on Seronegative mFAS</title>
        <description>Percentage of participants with cumulative incidence of death in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) up to Day 29 from randomization were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.</description>
        <time_frame>Up to Day 29</time_frame>
        <population>The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 3: Cohort 1 (Placebo)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1</description>
          </group>
          <group group_id="O2">
            <title>Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O3">
            <title>Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O4">
            <title>Phase 3 (Cohort 1): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O5">
            <title>Phase 2: Cohort 1A (Placebo)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O6">
            <title>Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O7">
            <title>Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A</description>
          </group>
          <group group_id="O8">
            <title>Phase 2: Cohort 1A Combined R10933+R10987</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg or 8000 mg) intravenously on Day 1 in Cohort 1A.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death up to Day 29 Based on Seronegative mFAS</title>
          <description>Percentage of participants with cumulative incidence of death in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) up to Day 29 from randomization were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.</description>
          <population>The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
          <units>Cumulative Incidence Percentage</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="70"/>
                <count group_id="O3" value="70"/>
                <count group_id="O4" value="140"/>
                <count group_id="O5" value="70"/>
                <count group_id="O6" value="78"/>
                <count group_id="O7" value="90"/>
                <count group_id="O8" value="168"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.6" lower_limit="15.1" upper_limit="35.6"/>
                    <measurement group_id="O2" value="7.8" lower_limit="3.6" upper_limit="16.5"/>
                    <measurement group_id="O3" value="11.4" lower_limit="6.1" upper_limit="20.7"/>
                    <measurement group_id="O4" value="9.6" lower_limit="5.9" upper_limit="15.4"/>
                    <measurement group_id="O5" value="9.6" lower_limit="4.9" upper_limit="18.3"/>
                    <measurement group_id="O6" value="3.6" lower_limit="1.2" upper_limit="10.9"/>
                    <measurement group_id="O7" value="5.9" lower_limit="2.7" upper_limit="12.8"/>
                    <measurement group_id="O8" value="4.8" lower_limit="2.6" upper_limit="9.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on Seronegative mFAS</title>
        <description>Percentage of participants with cumulative incidence of mechanical ventilation in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) by Day 29 were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.</description>
        <time_frame>by Day 29</time_frame>
        <population>The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 3: Cohort 1 (Placebo)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1</description>
          </group>
          <group group_id="O2">
            <title>Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O3">
            <title>Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1</description>
          </group>
          <group group_id="O4">
            <title>Phase 3 (Cohort 1): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O5">
            <title>Phase 2: Cohort 1A (Placebo)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O6">
            <title>Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)</title>
            <description>Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV) Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A</description>
          </group>
          <group group_id="O7">
            <title>Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A</description>
          </group>
          <group group_id="O8">
            <title>Phase 2 (Cohort 1A): Combined R10933+R10987 IV</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on Seronegative mFAS</title>
          <description>Percentage of participants with cumulative incidence of mechanical ventilation in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) by Day 29 were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.</description>
          <population>The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
          <units>Cumulative Incidence Percentage</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="66"/>
                <count group_id="O3" value="62"/>
                <count group_id="O4" value="128"/>
                <count group_id="O5" value="68"/>
                <count group_id="O6" value="77"/>
                <count group_id="O7" value="90"/>
                <count group_id="O8" value="167"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.2" lower_limit="10.8" upper_limit="30.0"/>
                    <measurement group_id="O2" value="8.9" lower_limit="4.4" upper_limit="17.8"/>
                    <measurement group_id="O3" value="17.6" lower_limit="10.8" upper_limit="27.9"/>
                    <measurement group_id="O4" value="13.4" lower_limit="8.9" upper_limit="19.8"/>
                    <measurement group_id="O5" value="4.7" lower_limit="1.8" upper_limit="12.1"/>
                    <measurement group_id="O6" value="3.5" lower_limit="1.1" upper_limit="10.5"/>
                    <measurement group_id="O7" value="0.0" lower_limit="0.0" upper_limit="0.0"/>
                    <measurement group_id="O8" value="1.7" lower_limit="0.5" upper_limit="5.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on Seronegative mFAS</title>
        <description>Percentage of participants with cumulative incidence of death or mechanical ventilation in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) by Day 29 were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.</description>
        <time_frame>by Day 29</time_frame>
        <population>The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 3: Cohort 1 (Placebo)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1</description>
          </group>
          <group group_id="O2">
            <title>Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O3">
            <title>Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1</description>
          </group>
          <group group_id="O4">
            <title>Phase 3 (Cohort 1): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O5">
            <title>Phase 2: Cohort 1A (Placebo)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O6">
            <title>Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O7">
            <title>Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O8">
            <title>Phase 2 (Cohort 1A): Combined R10933+R10987 IV</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on Seronegative mFAS</title>
          <description>Percentage of participants with cumulative incidence of death or mechanical ventilation in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) by Day 29 were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.</description>
          <population>The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
          <units>Cumulative Incidence Percentage</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="66"/>
                <count group_id="O3" value="62"/>
                <count group_id="O4" value="128"/>
                <count group_id="O5" value="68"/>
                <count group_id="O6" value="77"/>
                <count group_id="O7" value="90"/>
                <count group_id="O8" value="167"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.4" lower_limit="21.0" upper_limit="42.7"/>
                    <measurement group_id="O2" value="12.7" lower_limit="7.0" upper_limit="22.3"/>
                    <measurement group_id="O3" value="21.2" lower_limit="13.8" upper_limit="31.9"/>
                    <measurement group_id="O4" value="17.0" lower_limit="12.0" upper_limit="23.8"/>
                    <measurement group_id="O5" value="11.8" lower_limit="6.5" upper_limit="20.8"/>
                    <measurement group_id="O6" value="4.7" lower_limit="1.8" upper_limit="12.1"/>
                    <measurement group_id="O7" value="5.9" lower_limit="2.7" upper_limit="12.8"/>
                    <measurement group_id="O8" value="5.4" lower_limit="2.9" upper_limit="9.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on Seronegative mFAS</title>
        <description>Time to discharge from hospital up to Day 56 was reported.</description>
        <time_frame>Up to Day 56</time_frame>
        <population>The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 3: Cohort 1 (Placebo)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1</description>
          </group>
          <group group_id="O2">
            <title>Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O3">
            <title>Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O4">
            <title>Phase 3 (Cohort 1): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O5">
            <title>Phase 2: Cohort 1A (Placebo)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O6">
            <title>Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A</description>
          </group>
          <group group_id="O7">
            <title>Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O8">
            <title>Phase 2 (Cohort 1A): Combined R10933+R10987 IV</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on Seronegative mFAS</title>
          <description>Time to discharge from hospital up to Day 56 was reported.</description>
          <population>The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="80"/>
                <count group_id="O3" value="82"/>
                <count group_id="O4" value="162"/>
                <count group_id="O5" value="90"/>
                <count group_id="O6" value="86"/>
                <count group_id="O7" value="99"/>
                <count group_id="O8" value="198"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.5" lower_limit="5.0" upper_limit="15.0"/>
                    <measurement group_id="O2" value="5.0" lower_limit="4.0" upper_limit="7.0"/>
                    <measurement group_id="O3" value="6.0" lower_limit="4.0" upper_limit="9.0"/>
                    <measurement group_id="O4" value="6.0" lower_limit="4.0" upper_limit="7.0"/>
                    <measurement group_id="O5" value="4.0" lower_limit="3.0" upper_limit="4.0"/>
                    <measurement group_id="O6" value="3.0" lower_limit="2.0" upper_limit="4.0"/>
                    <measurement group_id="O7" value="3.0" lower_limit="2.0" upper_limit="4.0"/>
                    <measurement group_id="O8" value="3.0" lower_limit="2.0" upper_limit="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0370</p_value>
            <method>stratified log-rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1596</p_value>
            <method>stratified log-rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0444</p_value>
            <method>stratified log-rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1802</p_value>
            <method>stratified log-rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0407</p_value>
            <method>stratified log-rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0523</p_value>
            <method>stratified log-rank test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: TWA Change From Baseline Viral Load (Seronegative mFAS) in NP Samples up to Day 11 Based on Seronegative mFAS</title>
        <description>TWA change from baseline in viral load up to Day 11 was calculated for each participant using the trapezoidal rule as the area under the curve for change from baseline at each time point divided by the time interval for the observation period. TWA change from baseline viral load in NP samples through Day 11, was measured by RT-qPCR in NP swab samples was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicate improvement in viral load.</description>
        <time_frame>Day 1 to Day 11</time_frame>
        <population>The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 3: Cohort 1 (Placebo)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1</description>
          </group>
          <group group_id="O2">
            <title>Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O3">
            <title>Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O4">
            <title>Phase 3 (Cohort 1): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O5">
            <title>Phase 2: Cohort 1A (Placebo)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O6">
            <title>Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O7">
            <title>Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O8">
            <title>Phase 2 (Cohort 1A): Combined R10933+R10987 IV</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: TWA Change From Baseline Viral Load (Seronegative mFAS) in NP Samples up to Day 11 Based on Seronegative mFAS</title>
          <description>TWA change from baseline in viral load up to Day 11 was calculated for each participant using the trapezoidal rule as the area under the curve for change from baseline at each time point divided by the time interval for the observation period. TWA change from baseline viral load in NP samples through Day 11, was measured by RT-qPCR in NP swab samples was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicate improvement in viral load.</description>
          <population>The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
          <units>log10 copies/mL</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
                <count group_id="O2" value="76"/>
                <count group_id="O3" value="78"/>
                <count group_id="O4" value="154"/>
                <count group_id="O5" value="80"/>
                <count group_id="O6" value="79"/>
                <count group_id="O7" value="88"/>
                <count group_id="O8" value="167"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.52" spread="0.17"/>
                    <measurement group_id="O2" value="-2.03" spread="0.15"/>
                    <measurement group_id="O3" value="-1.95" spread="0.15"/>
                    <measurement group_id="O4" value="-2.00" spread="0.10"/>
                    <measurement group_id="O5" value="-1.28" spread="0.14"/>
                    <measurement group_id="O6" value="-1.88" spread="0.14"/>
                    <measurement group_id="O7" value="-2.01" spread="0.14"/>
                    <measurement group_id="O8" value="-1.95" spread="0.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0245</p_value>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0554</p_value>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0179</p_value>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0035</p_value>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0003</p_value>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0002</p_value>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: TWA Change From Baseline Viral Load (Seronegative mFAS) in NP Samples up to Day 29</title>
        <description>TWA change from baseline in viral load up to Day 29 was calculated for each participant using the trapezoidal rule as the area under the curve for change from baseline at each time point divided by the time interval for the observation period. TWA change from baseline viral load in NP samples through Day 29, was measured by quantitative RT-qPCR in NP swab samples was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicate improvement in viral load.</description>
        <time_frame>Day 1 to Day 29</time_frame>
        <population>The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 3: Cohort 1 (Placebo)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1</description>
          </group>
          <group group_id="O2">
            <title>Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O3">
            <title>Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O4">
            <title>Phase 3 (Cohort 1): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O5">
            <title>Phase 2: Cohort 1A (Placebo)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O6">
            <title>Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O7">
            <title>Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O8">
            <title>Phase 2 (Cohort 1A): Combined R10933+R10987 IV</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: TWA Change From Baseline Viral Load (Seronegative mFAS) in NP Samples up to Day 29</title>
          <description>TWA change from baseline in viral load up to Day 29 was calculated for each participant using the trapezoidal rule as the area under the curve for change from baseline at each time point divided by the time interval for the observation period. TWA change from baseline viral load in NP samples through Day 29, was measured by quantitative RT-qPCR in NP swab samples was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicate improvement in viral load.</description>
          <population>The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
          <units>log10 copies/mL</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
                <count group_id="O2" value="77"/>
                <count group_id="O3" value="79"/>
                <count group_id="O4" value="156"/>
                <count group_id="O5" value="84"/>
                <count group_id="O6" value="82"/>
                <count group_id="O7" value="93"/>
                <count group_id="O8" value="175"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.72" spread="0.22"/>
                    <measurement group_id="O2" value="-3.68" spread="0.20"/>
                    <measurement group_id="O3" value="-3.69" spread="0.20"/>
                    <measurement group_id="O4" value="-3.69" spread="0.14"/>
                    <measurement group_id="O5" value="-2.66" spread="0.21"/>
                    <measurement group_id="O6" value="-3.31" spread="0.21"/>
                    <measurement group_id="O7" value="-3.58" spread="0.20"/>
                    <measurement group_id="O8" value="-3.45" spread="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0013</p_value>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0010</p_value>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0002</p_value>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0250</p_value>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0012</p_value>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0014</p_value>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time</title>
        <description>Change from baseline in viral load as measured by RT-qPCR in NP swabs over time was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicates improvement in viral load.</description>
        <time_frame>Days 3, 5, 7, 9, 11, 13, 15, 22 and 29</time_frame>
        <population>The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. &quot;Number of Participants Analyzed&quot; = participants with measurements at baseline. &quot;Number Analyzed&quot; = participants with measurements for both baseline and the specific study day. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 3: Cohort 1 (Placebo)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1</description>
          </group>
          <group group_id="O2">
            <title>Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O3">
            <title>Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O4">
            <title>Phase 3 (Cohort 1): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O5">
            <title>Phase 2: Cohort 1A (Placebo)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O6">
            <title>Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O7">
            <title>Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O8">
            <title>Phase 2 (Cohort 1A): Combined R10933+R10987 IV</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time</title>
          <description>Change from baseline in viral load as measured by RT-qPCR in NP swabs over time was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicates improvement in viral load.</description>
          <population>The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. &quot;Number of Participants Analyzed&quot; = participants with measurements at baseline. &quot;Number Analyzed&quot; = participants with measurements for both baseline and the specific study day. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
          <units>log10 copies/mL</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="80"/>
                <count group_id="O3" value="82"/>
                <count group_id="O4" value="162"/>
                <count group_id="O5" value="90"/>
                <count group_id="O6" value="92"/>
                <count group_id="O7" value="106"/>
                <count group_id="O8" value="198"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Day 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="68"/>
                    <count group_id="O3" value="69"/>
                    <count group_id="O4" value="137"/>
                    <count group_id="O5" value="62"/>
                    <count group_id="O6" value="68"/>
                    <count group_id="O7" value="76"/>
                    <count group_id="O8" value="144"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.10" spread="0.22"/>
                    <measurement group_id="O2" value="-0.90" spread="0.19"/>
                    <measurement group_id="O3" value="-0.93" spread="0.19"/>
                    <measurement group_id="O4" value="-0.92" spread="0.14"/>
                    <measurement group_id="O5" value="-0.85" spread="0.21"/>
                    <measurement group_id="O6" value="-1.03" spread="0.20"/>
                    <measurement group_id="O7" value="-1.41" spread="0.19"/>
                    <measurement group_id="O8" value="-1.23" spread="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="62"/>
                    <count group_id="O3" value="54"/>
                    <count group_id="O4" value="116"/>
                    <count group_id="O5" value="50"/>
                    <count group_id="O6" value="44"/>
                    <count group_id="O7" value="53"/>
                    <count group_id="O8" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.97" spread="0.27"/>
                    <measurement group_id="O2" value="-2.28" spread="0.23"/>
                    <measurement group_id="O3" value="-1.91" spread="0.25"/>
                    <measurement group_id="O4" value="-2.11" spread="0.17"/>
                    <measurement group_id="O5" value="-1.55" spread="0.25"/>
                    <measurement group_id="O6" value="-2.21" spread="0.26"/>
                    <measurement group_id="O7" value="-2.24" spread="0.24"/>
                    <measurement group_id="O8" value="-2.21" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="50"/>
                    <count group_id="O3" value="55"/>
                    <count group_id="O4" value="105"/>
                    <count group_id="O5" value="42"/>
                    <count group_id="O6" value="46"/>
                    <count group_id="O7" value="45"/>
                    <count group_id="O8" value="91"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.97" spread="0.30"/>
                    <measurement group_id="O2" value="-2.92" spread="0.26"/>
                    <measurement group_id="O3" value="-3.22" spread="0.25"/>
                    <measurement group_id="O4" value="-3.09" spread="0.18"/>
                    <measurement group_id="O5" value="-2.29" spread="0.26"/>
                    <measurement group_id="O6" value="-3.06" spread="0.25"/>
                    <measurement group_id="O7" value="-3.49" spread="0.24"/>
                    <measurement group_id="O8" value="-3.27" spread="0.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="49"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="36"/>
                    <count group_id="O6" value="42"/>
                    <count group_id="O7" value="49"/>
                    <count group_id="O8" value="91"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.56" spread="0.32"/>
                    <measurement group_id="O2" value="-3.89" spread="0.27"/>
                    <measurement group_id="O3" value="-4.16" spread="0.27"/>
                    <measurement group_id="O4" value="-4.03" spread="0.19"/>
                    <measurement group_id="O5" value="-2.90" spread="0.28"/>
                    <measurement group_id="O6" value="-3.75" spread="0.26"/>
                    <measurement group_id="O7" value="-3.85" spread="0.24"/>
                    <measurement group_id="O8" value="-3.80" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="31"/>
                    <count group_id="O2" value="47"/>
                    <count group_id="O3" value="45"/>
                    <count group_id="O4" value="92"/>
                    <count group_id="O5" value="31"/>
                    <count group_id="O6" value="38"/>
                    <count group_id="O7" value="47"/>
                    <count group_id="O8" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.22" spread="0.35"/>
                    <measurement group_id="O2" value="-4.23" spread="0.29"/>
                    <measurement group_id="O3" value="-4.57" spread="0.30"/>
                    <measurement group_id="O4" value="-4.41" spread="0.21"/>
                    <measurement group_id="O5" value="-3.88" spread="0.32"/>
                    <measurement group_id="O6" value="-4.76" spread="0.30"/>
                    <measurement group_id="O7" value="-4.34" spread="0.27"/>
                    <measurement group_id="O8" value="-4.52" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="45"/>
                    <count group_id="O3" value="47"/>
                    <count group_id="O4" value="92"/>
                    <count group_id="O5" value="37"/>
                    <count group_id="O6" value="43"/>
                    <count group_id="O7" value="50"/>
                    <count group_id="O8" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.76" spread="0.35"/>
                    <measurement group_id="O2" value="-5.18" spread="0.30"/>
                    <measurement group_id="O3" value="-5.00" spread="0.29"/>
                    <measurement group_id="O4" value="-5.10" spread="0.21"/>
                    <measurement group_id="O5" value="-4.22" spread="0.31"/>
                    <measurement group_id="O6" value="-4.56" spread="0.29"/>
                    <measurement group_id="O7" value="-5.05" spread="0.27"/>
                    <measurement group_id="O8" value="-4.82" spread="0.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="47"/>
                    <count group_id="O3" value="51"/>
                    <count group_id="O4" value="98"/>
                    <count group_id="O5" value="45"/>
                    <count group_id="O6" value="47"/>
                    <count group_id="O7" value="57"/>
                    <count group_id="O8" value="104"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.42" spread="0.32"/>
                    <measurement group_id="O2" value="-5.41" spread="0.28"/>
                    <measurement group_id="O3" value="-5.25" spread="0.27"/>
                    <measurement group_id="O4" value="-5.34" spread="0.19"/>
                    <measurement group_id="O5" value="-4.14" spread="0.28"/>
                    <measurement group_id="O6" value="-5.03" spread="0.27"/>
                    <measurement group_id="O7" value="-5.23" spread="0.25"/>
                    <measurement group_id="O8" value="-5.14" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="47"/>
                    <count group_id="O3" value="47"/>
                    <count group_id="O4" value="94"/>
                    <count group_id="O5" value="36"/>
                    <count group_id="O6" value="40"/>
                    <count group_id="O7" value="53"/>
                    <count group_id="O8" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.29" spread="0.30"/>
                    <measurement group_id="O2" value="-5.74" spread="0.24"/>
                    <measurement group_id="O3" value="-5.95" spread="0.24"/>
                    <measurement group_id="O4" value="-5.85" spread="0.17"/>
                    <measurement group_id="O5" value="-5.37" spread="0.30"/>
                    <measurement group_id="O6" value="-5.75" spread="0.29"/>
                    <measurement group_id="O7" value="-5.77" spread="0.25"/>
                    <measurement group_id="O8" value="-5.75" spread="0.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="56"/>
                    <count group_id="O4" value="108"/>
                    <count group_id="O5" value="43"/>
                    <count group_id="O6" value="47"/>
                    <count group_id="O7" value="62"/>
                    <count group_id="O8" value="109"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.90" spread="0.24"/>
                    <measurement group_id="O2" value="-6.46" spread="0.18"/>
                    <measurement group_id="O3" value="-6.60" spread="0.18"/>
                    <measurement group_id="O4" value="-6.54" spread="0.13"/>
                    <measurement group_id="O5" value="-5.77" spread="0.27"/>
                    <measurement group_id="O6" value="-6.34" spread="0.26"/>
                    <measurement group_id="O7" value="-6.36" spread="0.23"/>
                    <measurement group_id="O8" value="-6.35" spread="0.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Difference vs. Placebo by Day 29</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0623</p_value>
            <method>MMRM</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Difference vs. Placebo by Day 29</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0203</p_value>
            <method>MMRM</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Difference vs. Placebo by Day 29</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0193</p_value>
            <method>MMRM</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Difference vs. Placebo by Day 29</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1206</p_value>
            <method>MMRM</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Difference vs. Placebo by Day 29</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0911</p_value>
            <method>MMRM</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <groups_desc>Difference vs. Placebo by Day 29</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0645</p_value>
            <method>MMRM</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time</title>
        <description>Percent change from baseline in viral load as measured by RT-qPCR in NP swabs over time was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicates improvement in viral load.</description>
        <time_frame>Days 3, 5, 7, 9, 11, 13, 15, 22 and 29</time_frame>
        <population>The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Number of Participants Analyzed&quot; = participants with measurements at baseline. &quot;Number Analyzed&quot; = participants with measurements for both baseline and the specific study day. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 3: Cohort 1 (Placebo)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1</description>
          </group>
          <group group_id="O2">
            <title>Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O3">
            <title>Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O4">
            <title>Phase 3 (Cohort 1): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O5">
            <title>Phase 2: Cohort 1A (Placebo)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O6">
            <title>Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O7">
            <title>Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A</description>
          </group>
          <group group_id="O8">
            <title>Phase 2 (Cohort 1A): Combined R10933+R10987 IV</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time</title>
          <description>Percent change from baseline in viral load as measured by RT-qPCR in NP swabs over time was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicates improvement in viral load.</description>
          <population>The seronegative mFAS was defined as all participants in mFAS with documented seronegative status at the baseline. Number of Participants Analyzed&quot; = participants with measurements at baseline. &quot;Number Analyzed&quot; = participants with measurements for both baseline and the specific study day. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
          <units>Percent Change</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="80"/>
                <count group_id="O3" value="82"/>
                <count group_id="O4" value="162"/>
                <count group_id="O5" value="90"/>
                <count group_id="O6" value="92"/>
                <count group_id="O7" value="106"/>
                <count group_id="O8" value="198"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Percent change at Day 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="68"/>
                    <count group_id="O3" value="69"/>
                    <count group_id="O4" value="137"/>
                    <count group_id="O5" value="62"/>
                    <count group_id="O6" value="68"/>
                    <count group_id="O7" value="76"/>
                    <count group_id="O8" value="144"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-92.04" lower_limit="-97.12" upper_limit="-78.01"/>
                    <measurement group_id="O2" value="-87.52" lower_limit="-94.82" upper_limit="-69.93"/>
                    <measurement group_id="O3" value="-88.15" lower_limit="-95.07" upper_limit="-71.52"/>
                    <measurement group_id="O4" value="-87.94" lower_limit="-93.51" upper_limit="-77.61"/>
                    <measurement group_id="O5" value="-85.92" lower_limit="-94.47" upper_limit="-64.12"/>
                    <measurement group_id="O6" value="-90.65" lower_limit="-96.19" upper_limit="-77.01"/>
                    <measurement group_id="O7" value="-96.15" lower_limit="-98.37" upper_limit="-90.90"/>
                    <measurement group_id="O8" value="-94.15" lower_limit="-96.86" upper_limit="-89.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent change at Day 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="62"/>
                    <count group_id="O3" value="54"/>
                    <count group_id="O4" value="116"/>
                    <count group_id="O5" value="50"/>
                    <count group_id="O6" value="44"/>
                    <count group_id="O7" value="53"/>
                    <count group_id="O8" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-98.92" lower_limit="-99.68" upper_limit="-96.35"/>
                    <measurement group_id="O2" value="-99.48" lower_limit="-99.82" upper_limit="-98.50"/>
                    <measurement group_id="O3" value="-98.76" lower_limit="-99.59" upper_limit="-96.20"/>
                    <measurement group_id="O4" value="-99.23" lower_limit="-99.64" upper_limit="-98.34"/>
                    <measurement group_id="O5" value="-97.18" lower_limit="-99.09" upper_limit="-91.23"/>
                    <measurement group_id="O6" value="-99.38" lower_limit="-99.81" upper_limit="-97.96"/>
                    <measurement group_id="O7" value="-99.42" lower_limit="-99.81" upper_limit="-98.26"/>
                    <measurement group_id="O8" value="-99.39" lower_limit="-99.73" upper_limit="-98.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent change at Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="50"/>
                    <count group_id="O3" value="55"/>
                    <count group_id="O4" value="105"/>
                    <count group_id="O5" value="42"/>
                    <count group_id="O6" value="46"/>
                    <count group_id="O7" value="45"/>
                    <count group_id="O8" value="91"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-98.92" lower_limit="-99.73" upper_limit="-95.76"/>
                    <measurement group_id="O2" value="-99.88" lower_limit="-99.96" upper_limit="-99.62"/>
                    <measurement group_id="O3" value="-99.94" lower_limit="-99.98" upper_limit="-99.82"/>
                    <measurement group_id="O4" value="-99.92" lower_limit="-99.96" upper_limit="-99.82"/>
                    <measurement group_id="O5" value="-99.49" lower_limit="-99.84" upper_limit="-98.36"/>
                    <measurement group_id="O6" value="-99.91" lower_limit="-99.97" upper_limit="-99.73"/>
                    <measurement group_id="O7" value="-99.97" lower_limit="-99.99" upper_limit="-99.90"/>
                    <measurement group_id="O8" value="-99.95" lower_limit="-99.98" upper_limit="-99.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent change at Day 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="49"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="36"/>
                    <count group_id="O6" value="42"/>
                    <count group_id="O7" value="49"/>
                    <count group_id="O8" value="91"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-99.72" lower_limit="-99.94" upper_limit="-98.80"/>
                    <measurement group_id="O2" value="-99.99" lower_limit="-100.00" upper_limit="-99.96"/>
                    <measurement group_id="O3" value="-99.99" lower_limit="-100.00" upper_limit="-99.98"/>
                    <measurement group_id="O4" value="-99.99" lower_limit="-100.00" upper_limit="-99.98"/>
                    <measurement group_id="O5" value="-99.87" lower_limit="-99.96" upper_limit="-99.56"/>
                    <measurement group_id="O6" value="-99.98" lower_limit="-99.99" upper_limit="-99.94"/>
                    <measurement group_id="O7" value="-99.99" lower_limit="-100.00" upper_limit="-99.96"/>
                    <measurement group_id="O8" value="-99.98" lower_limit="-99.99" upper_limit="-99.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent change at Day 11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="31"/>
                    <count group_id="O2" value="47"/>
                    <count group_id="O3" value="45"/>
                    <count group_id="O4" value="92"/>
                    <count group_id="O5" value="31"/>
                    <count group_id="O6" value="38"/>
                    <count group_id="O7" value="47"/>
                    <count group_id="O8" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-99.94" lower_limit="-99.99" upper_limit="-99.70"/>
                    <measurement group_id="O2" value="-99.99" lower_limit="-100.00" upper_limit="-99.98"/>
                    <measurement group_id="O3" value="-100.00" lower_limit="-100.00" upper_limit="-99.99"/>
                    <measurement group_id="O4" value="-100.00" lower_limit="-100.00" upper_limit="-99.99"/>
                    <measurement group_id="O5" value="-99.99" lower_limit="-100.00" upper_limit="-99.94"/>
                    <measurement group_id="O6" value="-100.00" lower_limit="-100.00" upper_limit="-99.99"/>
                    <measurement group_id="O7" value="-100.00" lower_limit="-100.00" upper_limit="-99.98"/>
                    <measurement group_id="O8" value="-100.00" lower_limit="-100.00" upper_limit="-99.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent change at Day 13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="45"/>
                    <count group_id="O3" value="47"/>
                    <count group_id="O4" value="92"/>
                    <count group_id="O5" value="37"/>
                    <count group_id="O6" value="43"/>
                    <count group_id="O7" value="50"/>
                    <count group_id="O8" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-99.98" lower_limit="-100.00" upper_limit="-99.91"/>
                    <measurement group_id="O2" value="-100.00" lower_limit="-100.00" upper_limit="-100.00"/>
                    <measurement group_id="O3" value="-100.00" lower_limit="-100.00" upper_limit="-100.00"/>
                    <measurement group_id="O4" value="-100.00" lower_limit="-100.00" upper_limit="-100.00"/>
                    <measurement group_id="O5" value="-99.99" lower_limit="-100.00" upper_limit="-99.98"/>
                    <measurement group_id="O6" value="-100.00" lower_limit="-100.00" upper_limit="-99.99"/>
                    <measurement group_id="O7" value="-100.00" lower_limit="-100.00" upper_limit="-100.00"/>
                    <measurement group_id="O8" value="-100.00" lower_limit="-100.00" upper_limit="-100.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent change at Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="47"/>
                    <count group_id="O3" value="51"/>
                    <count group_id="O4" value="98"/>
                    <count group_id="O5" value="45"/>
                    <count group_id="O6" value="47"/>
                    <count group_id="O7" value="57"/>
                    <count group_id="O8" value="104"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-100.00" lower_limit="-100.00" upper_limit="-99.98"/>
                    <measurement group_id="O2" value="-100.00" lower_limit="-100.00" upper_limit="-100.00"/>
                    <measurement group_id="O3" value="-100.00" lower_limit="-100.00" upper_limit="-100.00"/>
                    <measurement group_id="O4" value="-100.00" lower_limit="-100.00" upper_limit="-100.00"/>
                    <measurement group_id="O5" value="-99.99" lower_limit="-100.00" upper_limit="-99.97"/>
                    <measurement group_id="O6" value="-100.00" lower_limit="-100.00" upper_limit="-100.00"/>
                    <measurement group_id="O7" value="-100.00" lower_limit="-100.00" upper_limit="-100.00"/>
                    <measurement group_id="O8" value="-100.00" lower_limit="-100.00" upper_limit="-100.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent change at Day 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="47"/>
                    <count group_id="O3" value="47"/>
                    <count group_id="O4" value="94"/>
                    <count group_id="O5" value="36"/>
                    <count group_id="O6" value="40"/>
                    <count group_id="O7" value="53"/>
                    <count group_id="O8" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-100.00" lower_limit="-100.00" upper_limit="-100.00"/>
                    <measurement group_id="O2" value="-100.00" lower_limit="-100.00" upper_limit="-100.00"/>
                    <measurement group_id="O3" value="-100.00" lower_limit="-100.00" upper_limit="-100.00"/>
                    <measurement group_id="O4" value="-100.00" lower_limit="-100.00" upper_limit="-100.00"/>
                    <measurement group_id="O5" value="-100.00" lower_limit="-100.00" upper_limit="-100.00"/>
                    <measurement group_id="O6" value="-100.00" lower_limit="-100.00" upper_limit="-100.00"/>
                    <measurement group_id="O7" value="-100.00" lower_limit="-100.00" upper_limit="-100.00"/>
                    <measurement group_id="O8" value="-100.00" lower_limit="-100.00" upper_limit="-100.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent change at Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="56"/>
                    <count group_id="O4" value="108"/>
                    <count group_id="O5" value="43"/>
                    <count group_id="O6" value="47"/>
                    <count group_id="O7" value="62"/>
                    <count group_id="O8" value="109"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-100.00" lower_limit="-100.00" upper_limit="-100.00"/>
                    <measurement group_id="O2" value="-100.00" lower_limit="-100.00" upper_limit="-100.00"/>
                    <measurement group_id="O3" value="-100.00" lower_limit="-100.00" upper_limit="-100.00"/>
                    <measurement group_id="O4" value="-100.00" lower_limit="-100.00" upper_limit="-100.00"/>
                    <measurement group_id="O5" value="-100.00" lower_limit="-100.00" upper_limit="-100.00"/>
                    <measurement group_id="O6" value="-100.00" lower_limit="-100.00" upper_limit="-100.00"/>
                    <measurement group_id="O7" value="-100.00" lower_limit="-100.00" upper_limit="-100.00"/>
                    <measurement group_id="O8" value="-100.00" lower_limit="-100.00" upper_limit="-100.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Percent Difference vs. Placebo at Day 29</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0623</p_value>
            <method>MMRM</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Percent Difference vs. Placebo at Day 29</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0203</p_value>
            <method>MMRM</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Percent Difference vs. Placebo at Day 29</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0193</p_value>
            <method>MMRM</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Percent Difference vs. Placebo at Day 29</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1206</p_value>
            <method>MMRM</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Percent Difference vs. Placebo at Day 29</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0911</p_value>
            <method>MMRM</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <groups_desc>Percent Difference vs. Placebo at Day 29</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0645</p_value>
            <method>MMRM</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on High Viral Load mFAS</title>
        <description>Percentage of participants who went on mechanical ventilation in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.</description>
        <time_frame>by Day 29</time_frame>
        <population>The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (&gt;) 10^6 copies per milliliter (mL). Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 3: Cohort 1 (Placebo)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1</description>
          </group>
          <group group_id="O2">
            <title>Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O3">
            <title>Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O4">
            <title>Phase 3 (Cohort 1): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O5">
            <title>Phase 2: Cohort 1A (Placebo)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O6">
            <title>Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A</description>
          </group>
          <group group_id="O7">
            <title>Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O8">
            <title>Phase 2 (Cohort 1A): Combined R10933+R10987 IV</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on High Viral Load mFAS</title>
          <description>Percentage of participants who went on mechanical ventilation in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.</description>
          <population>The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (&gt;) 10^6 copies per milliliter (mL). Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="126"/>
                <count group_id="O2" value="129"/>
                <count group_id="O3" value="118"/>
                <count group_id="O4" value="247"/>
                <count group_id="O5" value="103"/>
                <count group_id="O6" value="102"/>
                <count group_id="O7" value="118"/>
                <count group_id="O8" value="220"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.5" lower_limit="11.3" upper_limit="25.2"/>
                    <measurement group_id="O2" value="8.5" lower_limit="4.3" upper_limit="14.7"/>
                    <measurement group_id="O3" value="16.9" lower_limit="10.7" upper_limit="25.0"/>
                    <measurement group_id="O4" value="12.6" lower_limit="8.7" upper_limit="17.3"/>
                    <measurement group_id="O5" value="3.9" lower_limit="1.1" upper_limit="9.6"/>
                    <measurement group_id="O6" value="2.9" lower_limit="0.6" upper_limit="8.4"/>
                    <measurement group_id="O7" value="0.0" lower_limit="0.0" upper_limit="0.0"/>
                    <measurement group_id="O8" value="1.4" lower_limit="0.3" upper_limit="3.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0481</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9880</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2498</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>1.0000</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0457</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2153</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 to Day 29 Based on High Viral Load mFAS</title>
        <description>Percentage of participants who died in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.</description>
        <time_frame>Day 6 to Day 29</time_frame>
        <population>The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (&gt;) 10^6 copies per milliliter (mL). Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 3: Cohort 1 (Placebo)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1</description>
          </group>
          <group group_id="O2">
            <title>Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O3">
            <title>Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O4">
            <title>Phase 3 (Cohort 1): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O5">
            <title>Phase 2: Cohort 1A (Placebo)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O6">
            <title>Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A</description>
          </group>
          <group group_id="O7">
            <title>Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O8">
            <title>Phase 2 (Cohort 1A): Combined R10933+R10987 IV</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 to Day 29 Based on High Viral Load mFAS</title>
          <description>Percentage of participants who died in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.</description>
          <population>The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (&gt;) 10^6 copies per milliliter (mL). Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="122"/>
                <count group_id="O2" value="128"/>
                <count group_id="O3" value="115"/>
                <count group_id="O4" value="243"/>
                <count group_id="O5" value="100"/>
                <count group_id="O6" value="98"/>
                <count group_id="O7" value="113"/>
                <count group_id="O8" value="211"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.0" lower_limit="11.7" upper_limit="26.0"/>
                    <measurement group_id="O2" value="10.2" lower_limit="5.5" upper_limit="16.7"/>
                    <measurement group_id="O3" value="15.7" lower_limit="9.5" upper_limit="23.6"/>
                    <measurement group_id="O4" value="12.8" lower_limit="8.8" upper_limit="17.6"/>
                    <measurement group_id="O5" value="7.0" lower_limit="2.9" upper_limit="13.9"/>
                    <measurement group_id="O6" value="3.1" lower_limit="0.6" upper_limit="8.7"/>
                    <measurement group_id="O7" value="4.4" lower_limit="1.5" upper_limit="10.0"/>
                    <measurement group_id="O8" value="3.8" lower_limit="1.7" upper_limit="7.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0811</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6701</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2006</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3313</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5542</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2214</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 to Day 29 Based on High Viral Load mFAS</title>
        <description>Percentage of participants who died in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.</description>
        <time_frame>Day 1 to Day 29</time_frame>
        <population>The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (&gt;) 10^6 copies per milliliter (mL). Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 3: Cohort 1 (Placebo)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1</description>
          </group>
          <group group_id="O2">
            <title>Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O3">
            <title>Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O4">
            <title>Phase 3 (Cohort 1): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O5">
            <title>Phase 2: Cohort 1A (Placebo)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O6">
            <title>Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O7">
            <title>Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O8">
            <title>Phase 2 (Cohort 1A): Combined R10933+R10987 IV</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 to Day 29 Based on High Viral Load mFAS</title>
          <description>Percentage of participants who died in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.</description>
          <population>The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (&gt;) 10^6 copies per milliliter (mL). Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="126"/>
                <count group_id="O2" value="129"/>
                <count group_id="O3" value="118"/>
                <count group_id="O4" value="247"/>
                <count group_id="O5" value="103"/>
                <count group_id="O6" value="102"/>
                <count group_id="O7" value="118"/>
                <count group_id="O8" value="220"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.6" lower_limit="13.9" upper_limit="28.8"/>
                    <measurement group_id="O2" value="10.9" lower_limit="6.1" upper_limit="17.5"/>
                    <measurement group_id="O3" value="16.9" lower_limit="10.7" upper_limit="25.0"/>
                    <measurement group_id="O4" value="13.8" lower_limit="9.7" upper_limit="18.7"/>
                    <measurement group_id="O5" value="6.8" lower_limit="2.8" upper_limit="13.5"/>
                    <measurement group_id="O6" value="2.9" lower_limit="0.6" upper_limit="8.4"/>
                    <measurement group_id="O7" value="5.1" lower_limit="1.9" upper_limit="10.7"/>
                    <measurement group_id="O8" value="4.1" lower_limit="1.9" upper_limit="7.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0389</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5208</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1079</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3315</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5797</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3036</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on High Viral Load mFAS</title>
        <description>Percentage of participants who were discharged in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.</description>
        <time_frame>by Day 29</time_frame>
        <population>The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (&gt;) 10^6 copies per milliliter (mL). Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 3: Cohort 1 (Placebo)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1</description>
          </group>
          <group group_id="O2">
            <title>Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O3">
            <title>Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O4">
            <title>Phase 3 (Cohort 1): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O5">
            <title>Phase 2: Cohort 1A (Placebo)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O6">
            <title>Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O7">
            <title>Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O8">
            <title>Phase 2 (Cohort 1A): Combined R10933+R10987 IV</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on High Viral Load mFAS</title>
          <description>Percentage of participants who were discharged in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.</description>
          <population>The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (&gt;) 10^6 copies per milliliter (mL). Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="126"/>
                <count group_id="O2" value="129"/>
                <count group_id="O3" value="118"/>
                <count group_id="O4" value="247"/>
                <count group_id="O5" value="103"/>
                <count group_id="O6" value="102"/>
                <count group_id="O7" value="118"/>
                <count group_id="O8" value="220"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.2" lower_limit="63.5" upper_limit="79.8"/>
                    <measurement group_id="O2" value="83.7" lower_limit="76.2" upper_limit="89.6"/>
                    <measurement group_id="O3" value="78.8" lower_limit="70.3" upper_limit="85.8"/>
                    <measurement group_id="O4" value="81.4" lower_limit="76.0" upper_limit="86.0"/>
                    <measurement group_id="O5" value="90.3" lower_limit="82.9" upper_limit="95.2"/>
                    <measurement group_id="O6" value="96.1" lower_limit="90.3" upper_limit="98.9"/>
                    <measurement group_id="O7" value="94.9" lower_limit="89.3" upper_limit="98.1"/>
                    <measurement group_id="O8" value="95.5" lower_limit="91.8" upper_limit="97.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0364</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2795</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0588</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0364</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2795</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0588</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital Over Time Based on High Viral Load mFAS</title>
        <description>Percentage of participants who died or were readmitted to hospital in phase 3 (Cohort 1) and phase 2 (Cohort 1A) over time were reported. Readmission to hospital was based on investigator report.</description>
        <time_frame>Up to Day 29</time_frame>
        <population>The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (&gt;) 10^6 copies per milliliter (mL). Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 3: Cohort 1 (Placebo)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1</description>
          </group>
          <group group_id="O2">
            <title>Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1</description>
          </group>
          <group group_id="O3">
            <title>Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O4">
            <title>Phase 3 (Cohort 1): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O5">
            <title>Phase 2: Cohort 1A (Placebo)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O6">
            <title>Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O7">
            <title>Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O8">
            <title>Phase 2 (Cohort 1A): Combined R10933+R10987 IV</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital Over Time Based on High Viral Load mFAS</title>
          <description>Percentage of participants who died or were readmitted to hospital in phase 3 (Cohort 1) and phase 2 (Cohort 1A) over time were reported. Readmission to hospital was based on investigator report.</description>
          <population>The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (&gt;) 10^6 copies per milliliter (mL). Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="126"/>
                <count group_id="O2" value="129"/>
                <count group_id="O3" value="118"/>
                <count group_id="O4" value="247"/>
                <count group_id="O5" value="103"/>
                <count group_id="O6" value="102"/>
                <count group_id="O7" value="118"/>
                <count group_id="O8" value="220"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.6" lower_limit="17.4" upper_limit="33.1"/>
                    <measurement group_id="O2" value="18.6" lower_limit="12.3" upper_limit="26.4"/>
                    <measurement group_id="O3" value="22.9" lower_limit="15.7" upper_limit="31.5"/>
                    <measurement group_id="O4" value="20.6" lower_limit="15.8" upper_limit="26.2"/>
                    <measurement group_id="O5" value="16.5" lower_limit="9.9" upper_limit="25.1"/>
                    <measurement group_id="O6" value="10.8" lower_limit="5.5" upper_limit="18.5"/>
                    <measurement group_id="O7" value="11.9" lower_limit="6.6" upper_limit="19.1"/>
                    <measurement group_id="O8" value="11.4" lower_limit="7.5" upper_limit="16.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2635</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8013</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4160</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2194</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3240</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1981</p_value>
            <p_value_desc>P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np &lt; =5 or n(1-p) &lt;= 5 in any treatment group, p-value is based on Fisher Exact Test.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death Over Time Based on High Viral Load mFAS</title>
        <description>Cumulative Incidence of Death Over Time in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.</description>
        <time_frame>Up to Day 29</time_frame>
        <population>The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (&gt;) 10^6 copies per milliliter (mL). Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 3: Cohort 1 (Placebo)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1</description>
          </group>
          <group group_id="O2">
            <title>Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O3">
            <title>Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O4">
            <title>Phase 3 (Cohort 1): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O5">
            <title>Phase 2: Cohort 1A (Placebo)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O6">
            <title>Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O7">
            <title>Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O8">
            <title>Phase 2 (Cohort 1A): Combined R10933+R10987 IV</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death Over Time Based on High Viral Load mFAS</title>
          <description>Cumulative Incidence of Death Over Time in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.</description>
          <population>The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (&gt;) 10^6 copies per milliliter (mL). Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
          <units>Cumulative Incidence Percentage</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="110"/>
                <count group_id="O3" value="90"/>
                <count group_id="O4" value="200"/>
                <count group_id="O5" value="85"/>
                <count group_id="O6" value="91"/>
                <count group_id="O7" value="100"/>
                <count group_id="O8" value="191"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.1" lower_limit="14.9" upper_limit="29.4"/>
                    <measurement group_id="O2" value="11.2" lower_limit="6.8" upper_limit="18.2"/>
                    <measurement group_id="O3" value="17.9" lower_limit="11.9" upper_limit="26.3"/>
                    <measurement group_id="O4" value="14.3" lower_limit="10.5" upper_limit="19.5"/>
                    <measurement group_id="O5" value="7.2" lower_limit="3.5" upper_limit="14.4"/>
                    <measurement group_id="O6" value="3.1" lower_limit="1.0" upper_limit="9.4"/>
                    <measurement group_id="O7" value="5.3" lower_limit="2.4" upper_limit="11.5"/>
                    <measurement group_id="O8" value="4.3" lower_limit="2.3" upper_limit="8.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation Over Time Based on High Viral Load mFAS</title>
        <description>Cumulative Incidence of Mechanical Ventilation Over Time in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.</description>
        <time_frame>Up to Day 29</time_frame>
        <population>The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (&gt;) 10^6 copies per milliliter (mL). Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 3: Cohort 1 (Placebo)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1</description>
          </group>
          <group group_id="O2">
            <title>Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O3">
            <title>Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O4">
            <title>Phase 3 (Cohort 1): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O5">
            <title>Phase 2: Cohort 1A (Placebo)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O6">
            <title>Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O7">
            <title>Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A</description>
          </group>
          <group group_id="O8">
            <title>Phase 2 (Cohort 1A): Combined R10933+R10987 IV</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation Over Time Based on High Viral Load mFAS</title>
          <description>Cumulative Incidence of Mechanical Ventilation Over Time in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.</description>
          <population>The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (&gt;) 10^6 copies per milliliter (mL). Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
          <units>Cumulative Incidence Percentage</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="87"/>
                <count group_id="O2" value="104"/>
                <count group_id="O3" value="83"/>
                <count group_id="O4" value="187"/>
                <count group_id="O5" value="83"/>
                <count group_id="O6" value="90"/>
                <count group_id="O7" value="100"/>
                <count group_id="O8" value="190"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.1" lower_limit="12.3" upper_limit="26.2"/>
                    <measurement group_id="O2" value="8.8" lower_limit="5.0" upper_limit="15.3"/>
                    <measurement group_id="O3" value="18.0" lower_limit="12.0" upper_limit="26.5"/>
                    <measurement group_id="O4" value="13.1" lower_limit="9.4" upper_limit="18.1"/>
                    <measurement group_id="O5" value="4.0" lower_limit="1.5" upper_limit="10.4"/>
                    <measurement group_id="O6" value="3.1" lower_limit="1.0" upper_limit="9.2"/>
                    <measurement group_id="O7" value="0.0" lower_limit="0.0" upper_limit="0.0"/>
                    <measurement group_id="O8" value="1.5" lower_limit="0.5" upper_limit="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation Over Time Based on High Viral Load mFAS</title>
        <description>Cumulative Incidence of Death or Mechanical Ventilation Over Time in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.</description>
        <time_frame>Up to Day 29</time_frame>
        <population>The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (&gt;) 10^6 copies per milliliter (mL). Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 3: Cohort 1 (Placebo)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1</description>
          </group>
          <group group_id="O2">
            <title>Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O3">
            <title>Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O4">
            <title>Phase 3 (Cohort 1): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O5">
            <title>Phase 2: Cohort 1A (Placebo)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O6">
            <title>Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O7">
            <title>Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O8">
            <title>Phase 2 (Cohort 1A): Combined R10933+R10987 IV</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation Over Time Based on High Viral Load mFAS</title>
          <description>Cumulative Incidence of Death or Mechanical Ventilation Over Time in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.</description>
          <population>The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (&gt;) 10^6 copies per milliliter (mL). Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
          <units>Cumulative Incidence Percentage</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="87"/>
                <count group_id="O2" value="104"/>
                <count group_id="O3" value="83"/>
                <count group_id="O4" value="187"/>
                <count group_id="O5" value="83"/>
                <count group_id="O6" value="90"/>
                <count group_id="O7" value="100"/>
                <count group_id="O8" value="190"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.2" lower_limit="20.2" upper_limit="35.9"/>
                    <measurement group_id="O2" value="15.0" lower_limit="9.8" upper_limit="22.5"/>
                    <measurement group_id="O3" value="24.4" lower_limit="17.6" upper_limit="33.4"/>
                    <measurement group_id="O4" value="19.5" lower_limit="15.0" upper_limit="25.1"/>
                    <measurement group_id="O5" value="9.1" lower_limit="4.9" upper_limit="16.8"/>
                    <measurement group_id="O6" value="4.1" lower_limit="1.6" upper_limit="10.5"/>
                    <measurement group_id="O7" value="5.3" lower_limit="2.4" upper_limit="11.5"/>
                    <measurement group_id="O8" value="4.8" lower_limit="2.6" upper_limit="8.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge Based on High Viral Load mFAS</title>
        <description>Time to Discharge in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported.</description>
        <time_frame>Up to Day 56</time_frame>
        <population>The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (&gt;) 10^6 copies per milliliter (mL). Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 3: Cohort 1 (Placebo)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1</description>
          </group>
          <group group_id="O2">
            <title>Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O3">
            <title>Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O4">
            <title>Phase 3 (Cohort 1): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1.</description>
          </group>
          <group group_id="O5">
            <title>Phase 2: Cohort 1A (Placebo)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O6">
            <title>Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O7">
            <title>Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.</description>
          </group>
          <group group_id="O8">
            <title>Phase 2 (Cohort 1A): Combined R10933+R10987 IV</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge Based on High Viral Load mFAS</title>
          <description>Time to Discharge in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported.</description>
          <population>The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (&gt;) 10^6 copies per milliliter (mL). Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 3 [Cohort 1] and Phase 2 [Cohort 1A].</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="126"/>
                <count group_id="O2" value="129"/>
                <count group_id="O3" value="118"/>
                <count group_id="O4" value="247"/>
                <count group_id="O5" value="103"/>
                <count group_id="O6" value="102"/>
                <count group_id="O7" value="118"/>
                <count group_id="O8" value="220"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.0" lower_limit="5.0" upper_limit="10.0"/>
                    <measurement group_id="O2" value="7.0" lower_limit="5.0" upper_limit="8.0"/>
                    <measurement group_id="O3" value="7.0" lower_limit="5.0" upper_limit="8.0"/>
                    <measurement group_id="O4" value="7.0" lower_limit="6.0" upper_limit="8.0"/>
                    <measurement group_id="O5" value="4.0" lower_limit="3.0" upper_limit="4.0"/>
                    <measurement group_id="O6" value="3.0" lower_limit="2.0" upper_limit="4.0"/>
                    <measurement group_id="O7" value="3.0" lower_limit="2.0" upper_limit="3.0"/>
                    <measurement group_id="O8" value="3.0" lower_limit="3.0" upper_limit="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Over Time Based on Seronegative mFAS</title>
        <description>Time-weighted average daily change over time up to Day 29 in viral load (log10 copies/mL), as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.</description>
        <time_frame>Up to Day 29</time_frame>
        <population>Seronegative modified full analysis set (mFAS) = all participants in mFAS with documented seroneg status at baseline. &quot;Number of Participants Analyzed&quot; = participants with measurements at baseline. &quot;Number Analyzed&quot; = participants with measurements at both baseline and specific study day. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected/reported for Phase 1 [Cohort 1] and Phase 2 [Cohort 1].</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Placebo</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching R10933+R10987 intravenously on Day 1</description>
          </group>
          <group group_id="O2">
            <title>Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (2400 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1</description>
          </group>
          <group group_id="O3">
            <title>Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1</description>
          </group>
          <group group_id="O4">
            <title>Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 Combined IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Over Time Based on Seronegative mFAS</title>
          <description>Time-weighted average daily change over time up to Day 29 in viral load (log10 copies/mL), as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.</description>
          <population>Seronegative modified full analysis set (mFAS) = all participants in mFAS with documented seroneg status at baseline. &quot;Number of Participants Analyzed&quot; = participants with measurements at baseline. &quot;Number Analyzed&quot; = participants with measurements at both baseline and specific study day. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected/reported for Phase 1 [Cohort 1] and Phase 2 [Cohort 1].</population>
          <units>log10 copies/milliliter (mL)</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="79"/>
                <count group_id="O3" value="70"/>
                <count group_id="O4" value="149"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Time-weighted average change from baseline from Day 1 to Day 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="46"/>
                    <count group_id="O4" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.33" spread="0.11"/>
                    <measurement group_id="O2" value="-0.40" spread="0.11"/>
                    <measurement group_id="O3" value="-0.60" spread="0.12"/>
                    <measurement group_id="O4" value="-0.50" spread="0.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Time-weighted average change from baseline from Day 1 to Day 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="58"/>
                    <count group_id="O2" value="57"/>
                    <count group_id="O3" value="52"/>
                    <count group_id="O4" value="109"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.55" spread="0.14"/>
                    <measurement group_id="O2" value="-0.86" spread="0.14"/>
                    <measurement group_id="O3" value="-0.92" spread="0.14"/>
                    <measurement group_id="O4" value="-0.89" spread="0.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Time-weighted average change from baseline from Day 1 to Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="61"/>
                    <count group_id="O2" value="60"/>
                    <count group_id="O3" value="55"/>
                    <count group_id="O4" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.70" spread="0.14"/>
                    <measurement group_id="O2" value="-1.23" spread="0.14"/>
                    <measurement group_id="O3" value="-1.23" spread="0.14"/>
                    <measurement group_id="O4" value="-1.23" spread="0.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Time-weighted average change from baseline from Day 1 to Day 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="61"/>
                    <count group_id="O2" value="61"/>
                    <count group_id="O3" value="57"/>
                    <count group_id="O4" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.93" spread="0.16"/>
                    <measurement group_id="O2" value="-1.47" spread="0.15"/>
                    <measurement group_id="O3" value="-1.58" spread="0.16"/>
                    <measurement group_id="O4" value="-1.52" spread="0.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Time-weighted average change from baseline from Day 1 to Day 11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="61"/>
                    <count group_id="O2" value="63"/>
                    <count group_id="O3" value="58"/>
                    <count group_id="O4" value="121"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.12" spread="0.16"/>
                    <measurement group_id="O2" value="-1.72" spread="0.16"/>
                    <measurement group_id="O3" value="-1.78" spread="0.17"/>
                    <measurement group_id="O4" value="-1.75" spread="0.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Time-weighted average change from baseline from Day 1 to Day 13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="61"/>
                    <count group_id="O2" value="64"/>
                    <count group_id="O3" value="58"/>
                    <count group_id="O4" value="122"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.33" spread="0.18"/>
                    <measurement group_id="O2" value="-1.96" spread="0.17"/>
                    <measurement group_id="O3" value="-1.95" spread="0.18"/>
                    <measurement group_id="O4" value="-1.96" spread="0.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Time-weighted average change from baseline from Day 1 to Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="61"/>
                    <count group_id="O2" value="64"/>
                    <count group_id="O3" value="58"/>
                    <count group_id="O4" value="122"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.50" spread="0.19"/>
                    <measurement group_id="O2" value="-2.19" spread="0.18"/>
                    <measurement group_id="O3" value="-2.16" spread="0.19"/>
                    <measurement group_id="O4" value="-2.18" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Time-weighted average change from baseline from Day 1 to Day 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="61"/>
                    <count group_id="O2" value="64"/>
                    <count group_id="O3" value="58"/>
                    <count group_id="O4" value="122"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.89" spread="0.22"/>
                    <measurement group_id="O2" value="-2.62" spread="0.21"/>
                    <measurement group_id="O3" value="-2.64" spread="0.22"/>
                    <measurement group_id="O4" value="-2.63" spread="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Time-weighted average change from baseline from Day 1 to Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="61"/>
                    <count group_id="O2" value="64"/>
                    <count group_id="O3" value="58"/>
                    <count group_id="O4" value="122"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.35" spread="0.24"/>
                    <measurement group_id="O2" value="-2.98" spread="0.23"/>
                    <measurement group_id="O3" value="-2.95" spread="0.24"/>
                    <measurement group_id="O4" value="-2.97" spread="0.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Change From Baseline as Measured by RT-qPCR in NP Swabs Over Time Based on Seronegative mFAS</title>
        <description>Change from baseline in viral load as measured by RT-qPCR in NP swabs over time was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicates improvement in viral load.</description>
        <time_frame>Days 3, 5, 7, 9, 11, 13, 15, 22 and 29</time_frame>
        <population>Seronegative modified full analysis set (mFAS) = all participants in mFAS with documented seroneg status at baseline. &quot;Number of Participants Analyzed&quot; = participants with measurements at baseline. &quot;Number Analyzed&quot; = participants with measurements at both baseline and specific study day. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected/reported for Phase 1 [Cohort 1] and Phase 2 [Cohort 1].</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Placebo</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching R10933+R10987 intravenously on Day 1</description>
          </group>
          <group group_id="O2">
            <title>Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (2400 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1</description>
          </group>
          <group group_id="O3">
            <title>Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1</description>
          </group>
          <group group_id="O4">
            <title>Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 Combined IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Change From Baseline as Measured by RT-qPCR in NP Swabs Over Time Based on Seronegative mFAS</title>
          <description>Change from baseline in viral load as measured by RT-qPCR in NP swabs over time was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicates improvement in viral load.</description>
          <population>Seronegative modified full analysis set (mFAS) = all participants in mFAS with documented seroneg status at baseline. &quot;Number of Participants Analyzed&quot; = participants with measurements at baseline. &quot;Number Analyzed&quot; = participants with measurements at both baseline and specific study day. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected/reported for Phase 1 [Cohort 1] and Phase 2 [Cohort 1].</population>
          <units>log10 copies/milliliter (mL)</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="79"/>
                <count group_id="O3" value="70"/>
                <count group_id="O4" value="149"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Time-weighted average change from baseline from Day 1 to Day 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="46"/>
                    <count group_id="O4" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.66" spread="0.22"/>
                    <measurement group_id="O2" value="-0.81" spread="0.21"/>
                    <measurement group_id="O3" value="-1.08" spread="0.23"/>
                    <measurement group_id="O4" value="-0.94" spread="0.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Time-weighted average change from baseline from Day 1 to Day 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="43"/>
                    <count group_id="O3" value="40"/>
                    <count group_id="O4" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.18" spread="0.26"/>
                    <measurement group_id="O2" value="-2.08" spread="0.26"/>
                    <measurement group_id="O3" value="-2.28" spread="0.27"/>
                    <measurement group_id="O4" value="-2.18" spread="0.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Time-weighted average change from baseline from Day 1 to Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="43"/>
                    <count group_id="O3" value="37"/>
                    <count group_id="O4" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.62" spread="0.30"/>
                    <measurement group_id="O2" value="-2.76" spread="0.27"/>
                    <measurement group_id="O3" value="-2.56" spread="0.29"/>
                    <measurement group_id="O4" value="-2.67" spread="0.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Time-weighted average change from baseline from Day 1 to Day 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.68" spread="0.34"/>
                    <measurement group_id="O2" value="-3.24" spread="0.31"/>
                    <measurement group_id="O3" value="-3.16" spread="0.32"/>
                    <measurement group_id="O4" value="-3.20" spread="0.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Time-weighted average change from baseline from Day 1 to Day 11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="31"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="33"/>
                    <count group_id="O4" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.55" spread="0.39"/>
                    <measurement group_id="O2" value="-3.74" spread="0.38"/>
                    <measurement group_id="O3" value="-3.94" spread="0.37"/>
                    <measurement group_id="O4" value="-3.87" spread="0.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Time-weighted average change from baseline from Day 1 to Day 13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="23"/>
                    <count group_id="O4" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.04" spread="0.38"/>
                    <measurement group_id="O2" value="-5.01" spread="0.35"/>
                    <measurement group_id="O3" value="-4.25" spread="0.39"/>
                    <measurement group_id="O4" value="-4.68" spread="0.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Time-weighted average change from baseline from Day 1 to Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="27"/>
                    <count group_id="O3" value="26"/>
                    <count group_id="O4" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.60" spread="0.39"/>
                    <measurement group_id="O2" value="-4.67" spread="0.35"/>
                    <measurement group_id="O3" value="-5.01" spread="0.36"/>
                    <measurement group_id="O4" value="-4.84" spread="0.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Time-weighted average change from baseline from Day 1 to Day 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="28"/>
                    <count group_id="O3" value="26"/>
                    <count group_id="O4" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.89" spread="0.37"/>
                    <measurement group_id="O2" value="-5.21" spread="0.31"/>
                    <measurement group_id="O3" value="-5.25" spread="0.32"/>
                    <measurement group_id="O4" value="-5.23" spread="0.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Time-weighted average change from baseline from Day 1 to Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="24"/>
                    <count group_id="O3" value="23"/>
                    <count group_id="O4" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.01" spread="0.32"/>
                    <measurement group_id="O2" value="-6.04" spread="0.27"/>
                    <measurement group_id="O3" value="-6.16" spread="0.28"/>
                    <measurement group_id="O4" value="-6.10" spread="0.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 1 [Cohort 1] and Phase 2 [Cohort 1]: Percentage of Participants Who Died or Went On Mechanical Ventilation by Day 29 Based on Seronegative mFAS</title>
        <time_frame>Through Day 29</time_frame>
        <population>Seronegative modified full analysis set (mFAS) was defined as all participants in mFAS with documented seronegative status at the baseline. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 1 [Cohort 1] and Phase 2 [Cohort 1].</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Placebo</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching R10933+R10987 intravenously on Day 1</description>
          </group>
          <group group_id="O2">
            <title>Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (2400 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1</description>
          </group>
          <group group_id="O3">
            <title>Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1</description>
          </group>
          <group group_id="O4">
            <title>Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of 2400mg or 8000 mg R10933+R10987 intravenously on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 1 [Cohort 1] and Phase 2 [Cohort 1]: Percentage of Participants Who Died or Went On Mechanical Ventilation by Day 29 Based on Seronegative mFAS</title>
          <population>Seronegative modified full analysis set (mFAS) was defined as all participants in mFAS with documented seronegative status at the baseline. As prespecified in protocol, pooled analysis of placebo and combined R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 1 [Cohort 1] and Phase 2 [Cohort 1].</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>80% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="62"/>
                <count group_id="O3" value="59"/>
                <count group_id="O4" value="121"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.9" lower_limit="19.0" upper_limit="34.8"/>
                    <measurement group_id="O2" value="17.7" lower_limit="11.5" upper_limit="24.0"/>
                    <measurement group_id="O3" value="22.0" lower_limit="15.1" upper_limit="28.9"/>
                    <measurement group_id="O4" value="19.8" lower_limit="15.2" upper_limit="24.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 1 [Cohort 1] and Phase 2 [Cohort 1]: Percentage of Participants Who Died or Went On Mechanical Ventilation by Day 29 Based on High Viral Load mFAS</title>
        <time_frame>Through Day 29</time_frame>
        <population>The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (&gt;) 10^6 copies per milliliter (mL). Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 1 [Cohort 1] and Phase 2 [Cohort 1].</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Placebo</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching R10933+R10987 intravenously on Day 1</description>
          </group>
          <group group_id="O2">
            <title>Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (2400 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1</description>
          </group>
          <group group_id="O3">
            <title>Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): R10933+R10987 (8000 mg IV)</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1</description>
          </group>
          <group group_id="O4">
            <title>Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Combined R10933+R10987 IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of 2400mg or 8000 mg R10933+R10987 intravenously on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 1 [Cohort 1] and Phase 2 [Cohort 1]: Percentage of Participants Who Died or Went On Mechanical Ventilation by Day 29 Based on High Viral Load mFAS</title>
          <population>The High Viral Load mFAS was defined as all participants in mFAS with baseline SARS-CoV-2 viral load greater than (&gt;) 10^6 copies per milliliter (mL). Here &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure. As prespecified in protocol, separate analysis for placebo and R10933+R10987 IV (2400 mg and 8000 mg combined doses) were collected and reported for Phase 1 [Cohort 1] and Phase 2 [Cohort 1].</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>80% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="78"/>
                <count group_id="O2" value="77"/>
                <count group_id="O3" value="80"/>
                <count group_id="O4" value="157"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.1" lower_limit="17.0" upper_limit="29.2"/>
                    <measurement group_id="O2" value="23.4" lower_limit="17.2" upper_limit="29.6"/>
                    <measurement group_id="O3" value="13.8" lower_limit="8.8" upper_limit="18.7"/>
                    <measurement group_id="O4" value="18.5" lower_limit="14.5" upper_limit="22.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 1 [Cohort 1]: Area Under the Concentration-Time Curve From Time 0 to 28 Days Post-dose (AUC0-28)</title>
        <time_frame>Up to Day 28</time_frame>
        <population>Participants in Phase 1 (Cohort 1) who received any study drug of casirivimab and imdevimab and who had at least 1 non-missing drug concentration measurement following the first dose of study drug</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 1 [Cohort 1]: R10983+10987 2400mg IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1</description>
          </group>
          <group group_id="O2">
            <title>Phase 1 [Cohort 1]: R10983+10987 8000mg IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 1 [Cohort 1]: Area Under the Concentration-Time Curve From Time 0 to 28 Days Post-dose (AUC0-28)</title>
          <population>Participants in Phase 1 (Cohort 1) who received any study drug of casirivimab and imdevimab and who had at least 1 non-missing drug concentration measurement following the first dose of study drug</population>
          <units>day*mg/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AUC0-28 of Casirivimab</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3026" spread="719"/>
                    <measurement group_id="O2" value="9678" spread="3362"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AUC0-28 of Imdevimab</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2582" spread="581"/>
                    <measurement group_id="O2" value="8680" spread="2930"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Concentration at the End of Infusion (Ceoi)</title>
        <time_frame>Day 1</time_frame>
        <population>Participants who received any study drug of casirivimab and imdevimab</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 1 [Cohort 1]: R10983+10987 2400mg IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 1 (Cohort 1).</description>
          </group>
          <group group_id="O2">
            <title>Phase 1 [Cohort 1]: R10983+10987 8000mg IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 1 (Cohort 1).</description>
          </group>
          <group group_id="O3">
            <title>Phase 2 (Cohort 1A): R10933+R10987 2400mg IV</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O4">
            <title>Phase 2 (Cohort 1A): R10933+R10987 8000mg IV</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O5">
            <title>Phase 2 (Cohort 1): R10933+R10987 2400mg IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 1).</description>
          </group>
          <group group_id="O6">
            <title>Phase 2 (Cohort 1): R10933+R10987 8000mg IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 1).</description>
          </group>
          <group group_id="O7">
            <title>Phase 2 (Cohort 2): R10933+R10987 2400mg IV</title>
            <description>Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 2).</description>
          </group>
          <group group_id="O8">
            <title>Phase 2 (Cohort 2): R10933+R10987 8000mg IV</title>
            <description>Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 2).</description>
          </group>
          <group group_id="O9">
            <title>Phase 2 (Cohort 3): R10933+R10987 2400mg IV</title>
            <description>Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).</description>
          </group>
          <group group_id="O10">
            <title>Phase 2 (Cohort 3): R10933+R10987 8000mg IV</title>
            <description>Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).</description>
          </group>
          <group group_id="O11">
            <title>Phase 3 (Cohort 1): R10933+R10987 2400mg IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 3 (Cohort 1).</description>
          </group>
          <group group_id="O12">
            <title>Phase 3 (Cohort 1): R10933+R10987 8000mg IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 3 (Cohort 1).</description>
          </group>
        </group_list>
        <measure>
          <title>Concentration at the End of Infusion (Ceoi)</title>
          <population>Participants who received any study drug of casirivimab and imdevimab</population>
          <units>milligrams per liter (mg/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="167"/>
                <count group_id="O4" value="155"/>
                <count group_id="O5" value="181"/>
                <count group_id="O6" value="178"/>
                <count group_id="O7" value="55"/>
                <count group_id="O8" value="50"/>
                <count group_id="O9" value="10"/>
                <count group_id="O10" value="11"/>
                <count group_id="O11" value="214"/>
                <count group_id="O12" value="207"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Ceoi of Casirivimab</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="167"/>
                    <count group_id="O4" value="155"/>
                    <count group_id="O5" value="181"/>
                    <count group_id="O6" value="178"/>
                    <count group_id="O7" value="55"/>
                    <count group_id="O8" value="50"/>
                    <count group_id="O9" value="10"/>
                    <count group_id="O10" value="11"/>
                    <count group_id="O11" value="214"/>
                    <count group_id="O12" value="207"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="231" spread="110"/>
                    <measurement group_id="O2" value="776" spread="372"/>
                    <measurement group_id="O3" value="272" spread="124"/>
                    <measurement group_id="O4" value="847" spread="300"/>
                    <measurement group_id="O5" value="288" spread="86.8"/>
                    <measurement group_id="O6" value="848" spread="261"/>
                    <measurement group_id="O7" value="286" spread="93.5"/>
                    <measurement group_id="O8" value="921" spread="262"/>
                    <measurement group_id="O9" value="284" spread="69.3"/>
                    <measurement group_id="O10" value="708" spread="128"/>
                    <measurement group_id="O11" value="307" spread="153"/>
                    <measurement group_id="O12" value="908" spread="338"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ceoi of Imdevimab</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="167"/>
                    <count group_id="O4" value="155"/>
                    <count group_id="O5" value="181"/>
                    <count group_id="O6" value="178"/>
                    <count group_id="O7" value="55"/>
                    <count group_id="O8" value="50"/>
                    <count group_id="O9" value="10"/>
                    <count group_id="O10" value="11"/>
                    <count group_id="O11" value="214"/>
                    <count group_id="O12" value="207"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="243" spread="117"/>
                    <measurement group_id="O2" value="795" spread="371"/>
                    <measurement group_id="O3" value="283" spread="127"/>
                    <measurement group_id="O4" value="868" spread="298"/>
                    <measurement group_id="O5" value="300" spread="87.3"/>
                    <measurement group_id="O6" value="880" spread="268"/>
                    <measurement group_id="O7" value="302" spread="94.0"/>
                    <measurement group_id="O8" value="946" spread="244"/>
                    <measurement group_id="O9" value="290" spread="81.7"/>
                    <measurement group_id="O10" value="738" spread="124"/>
                    <measurement group_id="O11" value="312" spread="157"/>
                    <measurement group_id="O12" value="945" spread="351"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Concentration at Day 28 (C28)</title>
        <time_frame>Day 28</time_frame>
        <population>Participants who received any study drug of casirivimab and imdevimab and who had at least 1 non-missing drug concentration measurement following the first dose of study drug</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 1 [Cohort 1]: R10983+10987 2400mg IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 1 (Cohort 1).</description>
          </group>
          <group group_id="O2">
            <title>Phase 1 [Cohort 1]: R10983+10987 8000mg IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 1 (Cohort 1)</description>
          </group>
          <group group_id="O3">
            <title>Phase 2 (Cohort 1A): R10933+R10987 2400mg IV</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O4">
            <title>Phase 2 (Cohort 1A): R10933+R10987 8000mg IV</title>
            <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
          </group>
          <group group_id="O5">
            <title>Phase 2 (Cohort 1): R10933+R10987 2400mg IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 1).</description>
          </group>
          <group group_id="O6">
            <title>Phase 2 (Cohort 1): R10933+R10987 8000mg IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 1).</description>
          </group>
          <group group_id="O7">
            <title>Phase 2 (Cohort 2): R10933+R10987 2400mg IV</title>
            <description>Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 2).</description>
          </group>
          <group group_id="O8">
            <title>Phase 2 (Cohort 2): R10933+R10987 8000mg IV</title>
            <description>Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 2).</description>
          </group>
          <group group_id="O9">
            <title>Phase 2 (Cohort 3): R10933+R10987 2400mg IV</title>
            <description>Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).</description>
          </group>
          <group group_id="O10">
            <title>Phase 2 (Cohort 3): R10933+R10987 8000mg IV</title>
            <description>Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).</description>
          </group>
          <group group_id="O11">
            <title>Phase 3 (Cohort 1): R10933+R10987 2400mg IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 3 (Cohort 1).</description>
          </group>
          <group group_id="O12">
            <title>Phase 3 (Cohort 1): R10933+R10987 8000mg IV</title>
            <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 3 (Cohort 1).</description>
          </group>
        </group_list>
        <measure>
          <title>Concentration at Day 28 (C28)</title>
          <population>Participants who received any study drug of casirivimab and imdevimab and who had at least 1 non-missing drug concentration measurement following the first dose of study drug</population>
          <units>mg/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="91"/>
                <count group_id="O4" value="96"/>
                <count group_id="O5" value="91"/>
                <count group_id="O6" value="93"/>
                <count group_id="O7" value="25"/>
                <count group_id="O8" value="26"/>
                <count group_id="O9" value="3"/>
                <count group_id="O10" value="5"/>
                <count group_id="O11" value="149"/>
                <count group_id="O12" value="146"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>C28 of Casirivimab</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.7" spread="19.5"/>
                    <measurement group_id="O2" value="166" spread="108"/>
                    <measurement group_id="O3" value="64.8" spread="35.9"/>
                    <measurement group_id="O4" value="174" spread="65.1"/>
                    <measurement group_id="O5" value="50.0" spread="20.4"/>
                    <measurement group_id="O6" value="144" spread="89.8"/>
                    <measurement group_id="O7" value="26.4" spread="18.5"/>
                    <measurement group_id="O8" value="79.4" spread="61.4"/>
                    <measurement group_id="O9" value="9.06" spread="2.64"/>
                    <measurement group_id="O10" value="67.8" spread="31.1"/>
                    <measurement group_id="O11" value="49.1" spread="40.4"/>
                    <measurement group_id="O12" value="140" spread="66.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C28 of Imdevimab</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.1" spread="16.1"/>
                    <measurement group_id="O2" value="131" spread="84.1"/>
                    <measurement group_id="O3" value="54.7" spread="37.6"/>
                    <measurement group_id="O4" value="150" spread="62.9"/>
                    <measurement group_id="O5" value="39.8" spread="18.9"/>
                    <measurement group_id="O6" value="113" spread="68.8"/>
                    <measurement group_id="O7" value="18.7" spread="14.7"/>
                    <measurement group_id="O8" value="60.0" spread="53.9"/>
                    <measurement group_id="O9" value="5.25" spread="4.12"/>
                    <measurement group_id="O10" value="52.4" spread="24.7"/>
                    <measurement group_id="O11" value="40.8" spread="48.3"/>
                    <measurement group_id="O12" value="114" spread="62.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933</title>
        <time_frame>Through Day 169</time_frame>
        <population>ADA analysis set includes all treated participants from all phases/cohorts who received any amount of study drug and had at least one non-missing antibody variables result following the first dose of study drug or placebo.</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled Placebo</title>
            <description>Participants received single dose of placebo matching to R10933+R10987 intravenously on Day 1</description>
          </group>
          <group group_id="O2">
            <title>Pooled R10933+R10987 2400mg IV</title>
            <description>Participants received a single 2400mg intravenous dose of R10933+R10987</description>
          </group>
          <group group_id="O3">
            <title>Pooled REGN10933+REGN10987 8000mg IV</title>
            <description>Participants received a single 8000 mg intravenous dose of R10933+R10987</description>
          </group>
        </group_list>
        <measure>
          <title>Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933</title>
          <population>ADA analysis set includes all treated participants from all phases/cohorts who received any amount of study drug and had at least one non-missing antibody variables result following the first dose of study drug or placebo.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="503"/>
                <count group_id="O2" value="504"/>
                <count group_id="O3" value="497"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="489"/>
                    <measurement group_id="O2" value="471"/>
                    <measurement group_id="O3" value="484"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987</title>
        <time_frame>Through Day 169</time_frame>
        <population>ADA analysis set includes all treated participants from all phases/cohorts who received any amount of study drug and had at least one non-missing antibody variables result following the first dose of study drug or placebo.</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled Placebo</title>
            <description>Participants received a single intravenous dose of placebo matching R10933+R10987</description>
          </group>
          <group group_id="O2">
            <title>Pooled R10933+R10987 2400mg IV</title>
            <description>Participants received a single 2400mg dose of R10933+R10987 intravenously on Day 1</description>
          </group>
          <group group_id="O3">
            <title>Pooled REGN10933+REGN10987 8000mg IV</title>
            <description>Participants received a single 8000 mg dose of R10933+R10987 intravenously on Day 1</description>
          </group>
        </group_list>
        <measure>
          <title>Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987</title>
          <population>ADA analysis set includes all treated participants from all phases/cohorts who received any amount of study drug and had at least one non-missing antibody variables result following the first dose of study drug or placebo.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="503"/>
                <count group_id="O2" value="504"/>
                <count group_id="O3" value="497"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="467"/>
                    <measurement group_id="O2" value="444"/>
                    <measurement group_id="O3" value="463"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Immunogenicity as Measured by Neutralizing Antibody Status (NAb) to REGN10933</title>
        <time_frame>Through Day 57</time_frame>
        <population>NAb analysis set includes all Phase 2/3 treated participants who received any study drug, had at least one non-missing antibody result following the first dose of study drug, and either tested negative at all ADA sampling times or tested positive for ADA with at least one non-missing NAb result after first dose of the study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled (Phase 2/3) Placebo</title>
            <description>Participants received single dose of placebo matching to R10933+R10987 intravenously on Day 1</description>
          </group>
          <group group_id="O2">
            <title>Pooled (Phase 2/3) R10933+R10987 2400mg IV</title>
            <description>Participants received a single 2400mg intravenous dose of R10933+R10987</description>
          </group>
          <group group_id="O3">
            <title>Pooled (Phase 2/3) REGN10933+REGN10987 8000mg IV</title>
            <description>Participants received a single 8000 mg intravenous dose of R10933+R10987</description>
          </group>
        </group_list>
        <measure>
          <title>Immunogenicity as Measured by Neutralizing Antibody Status (NAb) to REGN10933</title>
          <population>NAb analysis set includes all Phase 2/3 treated participants who received any study drug, had at least one non-missing antibody result following the first dose of study drug, and either tested negative at all ADA sampling times or tested positive for ADA with at least one non-missing NAb result after first dose of the study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="503"/>
                <count group_id="O2" value="504"/>
                <count group_id="O3" value="497"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Anti-drug Antibody (ADA) Negative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="489"/>
                    <measurement group_id="O2" value="471"/>
                    <measurement group_id="O3" value="484"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutralizing antibody (NAb) Positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Immunogenicity as Measured by Neutralizing Antibody Status (NAb) to REGN10987</title>
        <time_frame>Through Day 57</time_frame>
        <population>NAb analysis set includes all Phase 2/3 treated participants who received any study drug, had at least one non-missing antibody result following the first dose of study drug, and either tested negative at all ADA sampling times or tested positive for ADA with at least one non-missing NAb result after first dose of the study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled (Phase 2/3) Placebo</title>
            <description>Participants received single dose of placebo matching to R10933+R10987 intravenously on Day 1</description>
          </group>
          <group group_id="O2">
            <title>Pooled (Phase 2/3) R10933+R10987 2400mg IV</title>
            <description>Participants received a single 2400mg intravenous dose of R10933+R10987</description>
          </group>
          <group group_id="O3">
            <title>Pooled (Phase 2/3) REGN10933+REGN10987 8000mg IV</title>
            <description>Participants received a single 8000 mg intravenous dose of R10933+R10987</description>
          </group>
        </group_list>
        <measure>
          <title>Immunogenicity as Measured by Neutralizing Antibody Status (NAb) to REGN10987</title>
          <population>NAb analysis set includes all Phase 2/3 treated participants who received any study drug, had at least one non-missing antibody result following the first dose of study drug, and either tested negative at all ADA sampling times or tested positive for ADA with at least one non-missing NAb result after first dose of the study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="503"/>
                <count group_id="O2" value="504"/>
                <count group_id="O3" value="497"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Anti-drug Antibody (ADA) Negative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="467"/>
                    <measurement group_id="O2" value="444"/>
                    <measurement group_id="O3" value="463"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutralizing antibody (NAb) Positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From first dose of study drug to Day 169</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Phase 1 Cohort 1: Placebo IV</title>
          <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 1 (Cohort 1).</description>
        </group>
        <group group_id="E2">
          <title>Phase 1 Cohort 1: R10933+R10987 2400mg IV</title>
          <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 milligrams (mg) intravenously on Day 1 in Phase 1 (Cohort 1).</description>
        </group>
        <group group_id="E3">
          <title>Phase 1 Cohort 1: R10933+R10987 8000mg IV</title>
          <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 1 (Cohort 1).</description>
        </group>
        <group group_id="E4">
          <title>Phase 2 Cohort 1A: Placebo IV</title>
          <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
        </group>
        <group group_id="E5">
          <title>Phase 2 Cohort 1A: R10933+R10987 2400mg IV</title>
          <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
        </group>
        <group group_id="E6">
          <title>Phase 2 Cohort 1A: R10933+R10987 8000mg IV</title>
          <description>Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 1A).</description>
        </group>
        <group group_id="E7">
          <title>Phase 2 Cohort 1: Placebo IV</title>
          <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 1).</description>
        </group>
        <group group_id="E8">
          <title>Phase 2 Cohort 1: R10933+R10987 2400mg IV</title>
          <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 1).</description>
        </group>
        <group group_id="E9">
          <title>Phase 2 Cohort 1: R10933+R10987 8000mg IV</title>
          <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 1).</description>
        </group>
        <group group_id="E10">
          <title>Phase 2 Cohort 2: Placebo IV</title>
          <description>Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 2).</description>
        </group>
        <group group_id="E11">
          <title>Phase 2 Cohort 2: R10933+R10987 2400mg IV</title>
          <description>Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 2).</description>
        </group>
        <group group_id="E12">
          <title>Phase 2 Cohort 2: R10933+R10987 8000mg IV</title>
          <description>Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 2).</description>
        </group>
        <group group_id="E13">
          <title>Phase 2 Cohort 3: Placebo IV</title>
          <description>Participants on mechanical ventilation received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 3).</description>
        </group>
        <group group_id="E14">
          <title>Phase 2 Cohort 3: R10933+R10987 2400mg IV</title>
          <description>Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).</description>
        </group>
        <group group_id="E15">
          <title>Phase 2 Cohort 3: R10933+R10987 8000mg IV</title>
          <description>Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).</description>
        </group>
        <group group_id="E16">
          <title>Phase 3 Cohort 1: Placebo IV</title>
          <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1).</description>
        </group>
        <group group_id="E17">
          <title>Phase 3 Cohort 1: R10933+R10987 2400mg IV</title>
          <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 3 (Cohort 1).</description>
        </group>
        <group group_id="E18">
          <title>Phase 3 Cohort 1: R10933+R10987 8000mg IV</title>
          <description>Participants with O2 saturation &gt; 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 3 (Cohort 1).</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (24.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="15" subjects_at_risk="198"/>
                <counts group_id="E5" subjects_affected="8" subjects_at_risk="202"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="197"/>
                <counts group_id="E7" subjects_affected="28" subjects_at_risk="204"/>
                <counts group_id="E8" subjects_affected="25" subjects_at_risk="206"/>
                <counts group_id="E9" subjects_affected="21" subjects_at_risk="205"/>
                <counts group_id="E10" subjects_affected="13" subjects_at_risk="51"/>
                <counts group_id="E11" subjects_affected="25" subjects_at_risk="56"/>
                <counts group_id="E12" subjects_affected="19" subjects_at_risk="54"/>
                <counts group_id="E13" subjects_affected="7" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="8" subjects_at_risk="12"/>
                <counts group_id="E15" subjects_affected="4" subjects_at_risk="11"/>
                <counts group_id="E16" subjects_affected="42" subjects_at_risk="247"/>
                <counts group_id="E17" subjects_affected="24" subjects_at_risk="246"/>
                <counts group_id="E18" subjects_affected="37" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="43" subjects_at_risk="198"/>
                <counts group_id="E5" subjects_affected="29" subjects_at_risk="202"/>
                <counts group_id="E6" subjects_affected="32" subjects_at_risk="197"/>
                <counts group_id="E7" subjects_affected="63" subjects_at_risk="204"/>
                <counts group_id="E8" subjects_affected="47" subjects_at_risk="206"/>
                <counts group_id="E9" subjects_affected="47" subjects_at_risk="205"/>
                <counts group_id="E10" subjects_affected="20" subjects_at_risk="51"/>
                <counts group_id="E11" subjects_affected="31" subjects_at_risk="56"/>
                <counts group_id="E12" subjects_affected="26" subjects_at_risk="54"/>
                <counts group_id="E13" subjects_affected="9" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="11" subjects_at_risk="12"/>
                <counts group_id="E15" subjects_affected="5" subjects_at_risk="11"/>
                <counts group_id="E16" subjects_affected="65" subjects_at_risk="247"/>
                <counts group_id="E17" subjects_affected="56" subjects_at_risk="246"/>
                <counts group_id="E18" subjects_affected="69" subjects_at_risk="246"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E14" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="4" subjects_affected="2" subjects_at_risk="247"/>
                <counts group_id="E17" events="2" subjects_affected="2" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Hypercoagulation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Sickle cell anaemia with crisis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="246"/>
                <counts group_id="E18" events="1" subjects_affected="1" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Acute left ventricular failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="2" subjects_affected="2" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="3" subjects_affected="3" subjects_at_risk="204"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Atrial tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E8" events="3" subjects_affected="3" subjects_at_risk="206"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="205"/>
                <counts group_id="E10" events="3" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E11" events="5" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E12" events="4" subjects_affected="3" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E15" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E16" events="2" subjects_affected="2" subjects_at_risk="247"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="246"/>
                <counts group_id="E18" events="1" subjects_affected="1" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="2" subjects_affected="2" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="2" subjects_affected="2" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Cardiac failure acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Cardiac failure chronic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="246"/>
                <counts group_id="E18" events="2" subjects_affected="2" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Cardio-respiratory arrest</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="4" subjects_affected="3" subjects_at_risk="247"/>
                <counts group_id="E17" events="3" subjects_affected="3" subjects_at_risk="246"/>
                <counts group_id="E18" events="2" subjects_affected="2" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Cardiogenic shock</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="2" subjects_affected="2" subjects_at_risk="247"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="246"/>
                <counts group_id="E18" events="1" subjects_affected="1" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Chronic left ventricular failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Myocarditis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="1" subjects_affected="1" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Pulseless electrical activity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="2" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Ventricular tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo positional</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Blindness unilateral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="1" subjects_affected="1" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Haematemesis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="1" subjects_affected="1" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Impaired gastric emptying</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Intestinal ischaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Lower gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Mallory-Weiss syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Retroperitoneal haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="1" subjects_affected="1" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Retroperitoneal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="1" subjects_affected="1" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="2" subjects_affected="2" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="4" subjects_affected="2" subjects_at_risk="246"/>
                <counts group_id="E18" events="2" subjects_affected="2" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="2" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="3" subjects_affected="3" subjects_at_risk="204"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="2" subjects_affected="2" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Generalised oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Multiple organ dysfunction syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E13" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="3" subjects_affected="3" subjects_at_risk="247"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="246"/>
                <counts group_id="E18" events="6" subjects_affected="6" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="1" subjects_affected="1" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Sudden cardiac death</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="1" subjects_affected="1" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Systemic inflammatory response syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute hepatic failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Hepatic cirrhosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Ischaemic hepatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaphylactic reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="1" subjects_affected="1" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Lung transplant rejection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E4" events="7" subjects_affected="7" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="6" subjects_affected="6" subjects_at_risk="197"/>
                <counts group_id="E7" events="6" subjects_affected="6" subjects_at_risk="204"/>
                <counts group_id="E8" events="4" subjects_affected="4" subjects_at_risk="206"/>
                <counts group_id="E9" events="7" subjects_affected="7" subjects_at_risk="205"/>
                <counts group_id="E10" events="4" subjects_affected="4" subjects_at_risk="51"/>
                <counts group_id="E11" events="7" subjects_affected="7" subjects_at_risk="56"/>
                <counts group_id="E12" events="10" subjects_affected="8" subjects_at_risk="54"/>
                <counts group_id="E13" events="2" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E14" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E15" events="2" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E16" events="10" subjects_affected="10" subjects_at_risk="247"/>
                <counts group_id="E17" events="5" subjects_affected="5" subjects_at_risk="246"/>
                <counts group_id="E18" events="9" subjects_affected="8" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Appendicitis perforated</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Arthritis bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Aspergillus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Burkholderia cepacia complex infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>COVID-19 pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="204"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="206"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="205"/>
                <counts group_id="E10" events="3" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E11" events="2" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E12" events="3" subjects_affected="3" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="5" subjects_affected="5" subjects_at_risk="247"/>
                <counts group_id="E17" events="3" subjects_affected="3" subjects_at_risk="246"/>
                <counts group_id="E18" events="7" subjects_affected="7" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Candida infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Candida sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E15" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Cytomegalovirus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Device related bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="2" subjects_affected="1" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Emphysematous cholecystitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="1" subjects_affected="1" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Encephalitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Enterococcal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Escherichia urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Fungaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="1" subjects_affected="1" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Herpes simplex</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Ophthalmic herpes zoster</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Osteomyelitis fungal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Perirectal abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Pneumococcal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E7" events="5" subjects_affected="5" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="3" subjects_affected="3" subjects_at_risk="205"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="2" subjects_affected="2" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="4" subjects_affected="3" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Pneumonia bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="3" subjects_affected="3" subjects_at_risk="204"/>
                <counts group_id="E8" events="4" subjects_affected="4" subjects_at_risk="206"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="205"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Pneumonia klebsiella</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Pneumonia serratia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Pneumonia staphylococcal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Post procedural infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Pseudomonal sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Pulmonary sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="3" subjects_affected="3" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Pyelonephritis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Scrotal abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="4" subjects_affected="4" subjects_at_risk="204"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E9" events="3" subjects_affected="3" subjects_at_risk="205"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="3" subjects_affected="3" subjects_at_risk="204"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="206"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="205"/>
                <counts group_id="E10" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E11" events="2" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="7" subjects_affected="6" subjects_at_risk="247"/>
                <counts group_id="E17" events="2" subjects_affected="2" subjects_at_risk="246"/>
                <counts group_id="E18" events="6" subjects_affected="5" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Serratia infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="1" subjects_affected="1" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Staphylococcal bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Staphylococcal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Staphylococcal sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Superinfection bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="2" subjects_affected="2" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Urinary tract candidiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Urinary tract infection enterococcal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Viral cardiomyopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Viral myocarditis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Acetabulum fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="1" subjects_affected="1" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Brain herniation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Endotracheal intubation complication</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="2" subjects_affected="2" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Gastrointestinal stoma complication</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Head injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="1" subjects_affected="1" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Pancreatic leak</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Post procedural complication</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Post procedural haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Stomal hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Toxicity to various agents</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood glucose increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>ECG signs of myocardial ischaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Fibrin D dimer increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Haemoglobin decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="1" subjects_affected="1" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="1" subjects_affected="1" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Inflammatory marker increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>International normalised ratio increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Klebsiella test positive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Mean arterial pressure increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Oxygen saturation decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="2" subjects_affected="1" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Acidosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Calciphylaxis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Failure to thrive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Hypernatraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Hypervolaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="1" subjects_affected="1" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Metabolic acidosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Type 2 diabetes mellitus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Compartment syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="1" subjects_affected="1" subjects_at_risk="246"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Appendix cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="1" subjects_affected="1" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Chronic myelomonocytic leukaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Colon cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of skin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebral haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Dementia Alzheimer's type</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Depressed level of consciousness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="1" subjects_affected="1" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="206"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="1" subjects_affected="1" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Haemorrhage intracranial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="1" subjects_affected="1" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Hydrocephalus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Metabolic encephalopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="2" subjects_affected="2" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Multiple sclerosis relapse</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="3" subjects_affected="3" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="246"/>
                <counts group_id="E18" events="1" subjects_affected="1" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Toxic encephalopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Transverse sinus thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Unresponsive to stimuli</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device occlusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Mental status changes</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E17" events="3" subjects_affected="3" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="204"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="206"/>
                <counts group_id="E9" events="3" subjects_affected="3" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E12" events="4" subjects_affected="4" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="4" subjects_affected="4" subjects_at_risk="247"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="246"/>
                <counts group_id="E18" events="1" subjects_affected="1" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>End stage renal disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="204"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Renal tubular injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Ureterolithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="204"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="2" subjects_affected="2" subjects_at_risk="247"/>
                <counts group_id="E17" events="3" subjects_affected="3" subjects_at_risk="246"/>
                <counts group_id="E18" events="4" subjects_affected="3" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="198"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E7" events="9" subjects_affected="7" subjects_at_risk="204"/>
                <counts group_id="E8" events="3" subjects_affected="3" subjects_at_risk="206"/>
                <counts group_id="E9" events="7" subjects_affected="7" subjects_at_risk="205"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E12" events="2" subjects_affected="2" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="9" subjects_affected="8" subjects_at_risk="247"/>
                <counts group_id="E17" events="8" subjects_affected="8" subjects_at_risk="246"/>
                <counts group_id="E18" events="6" subjects_affected="5" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Acute respiratory distress syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="204"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="4" subjects_affected="4" subjects_at_risk="56"/>
                <counts group_id="E12" events="2" subjects_affected="2" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="2" subjects_affected="2" subjects_at_risk="247"/>
                <counts group_id="E17" events="3" subjects_affected="3" subjects_at_risk="246"/>
                <counts group_id="E18" events="2" subjects_affected="2" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="198"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="202"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E7" events="6" subjects_affected="6" subjects_at_risk="204"/>
                <counts group_id="E8" events="10" subjects_affected="10" subjects_at_risk="206"/>
                <counts group_id="E9" events="5" subjects_affected="5" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="7" subjects_affected="7" subjects_at_risk="56"/>
                <counts group_id="E12" events="3" subjects_affected="3" subjects_at_risk="54"/>
                <counts group_id="E13" events="2" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E14" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E15" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E16" events="12" subjects_affected="11" subjects_at_risk="247"/>
                <counts group_id="E17" events="6" subjects_affected="6" subjects_at_risk="246"/>
                <counts group_id="E18" events="6" subjects_affected="5" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Alveolar lung disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Aspiration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="1" subjects_affected="1" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Atelectasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="1" subjects_affected="1" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="3" subjects_affected="2" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Idiopathic pulmonary fibrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Laryngeal stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Organising pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Pleuritic pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Pneumomediastinum</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="2" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="246"/>
                <counts group_id="E18" events="1" subjects_affected="1" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Pneumothorax spontaneous</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="2" subjects_affected="1" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Pulmonary artery thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="204"/>
                <counts group_id="E8" events="5" subjects_affected="5" subjects_at_risk="206"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="2" subjects_affected="2" subjects_at_risk="247"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="246"/>
                <counts group_id="E18" events="1" subjects_affected="1" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Pulmonary oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="246"/>
                <counts group_id="E18" events="1" subjects_affected="1" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Respiratory arrest</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Respiratory distress</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E5" events="3" subjects_affected="2" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="10" subjects_affected="9" subjects_at_risk="204"/>
                <counts group_id="E8" events="4" subjects_affected="4" subjects_at_risk="206"/>
                <counts group_id="E9" events="8" subjects_affected="6" subjects_at_risk="205"/>
                <counts group_id="E10" events="6" subjects_affected="5" subjects_at_risk="51"/>
                <counts group_id="E11" events="4" subjects_affected="4" subjects_at_risk="56"/>
                <counts group_id="E12" events="6" subjects_affected="5" subjects_at_risk="54"/>
                <counts group_id="E13" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E14" events="3" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="8" subjects_affected="7" subjects_at_risk="247"/>
                <counts group_id="E17" events="7" subjects_affected="7" subjects_at_risk="246"/>
                <counts group_id="E18" events="5" subjects_affected="5" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Tachypnoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Decubitus ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Subcutaneous emphysema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Ileostomy closure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Arteriosclerosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="1" subjects_affected="1" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Distributive shock</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Embolism venous</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="1" subjects_affected="1" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Hypertensive urgency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="1" subjects_affected="1" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="204"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="206"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="205"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Hypovolaemic shock</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Peripheral artery occlusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Shock</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Shock haemorrhagic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Venous thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Venous thrombosis limb</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (24.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="246"/>
                <counts group_id="E18" subjects_affected="2" subjects_at_risk="246"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Enterocolitis infectious</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="246"/>
                <counts group_id="E18" events="1" subjects_affected="1" subjects_at_risk="246"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="1" subjects_affected="1" subjects_at_risk="246"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Peroneal nerve palsy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E15" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="1" subjects_affected="1" subjects_at_risk="246"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Drug eruption</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="205"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" events="2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="247"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="246"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Trial Management</name_or_title>
      <organization>Regeneron Pharmaceuticals, Inc</organization>
      <phone>844-734-6643</phone>
      <email>clinicaltrials@regeneron.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04426695
org study id: R10933-10987-COV-2066
secondary id: 2020-002537-15
nct id: NCT04426695
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The primary objectives are:

      Pooled Phase 3 (Cohort 1) and Phase 2 (Cohort 1A)

        -  To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in
           reducing viral load of SARS-CoV-2

        -  To evaluate the clinical efficacy of REGN10933+REGN10987 compared to placebo, as
           measured by death or mechanical ventilation

      Phase 1/2 (Cohort 1)

        -  To exclude futility of REGN10933+REGN10987 compared to placebo, as measured by death or
           mechanical ventilation

        -  To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Phase 1/Phase 2/Phase 3
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Based on Seronegative mFAS
time frame: Day 1 to Day 7
description: Time-weighted average daily change from Day 1 to Day 7 in viral load (log10 copies/mL), as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.
measure: Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on High Viral Load mFAS
time frame: Day 6 to Day 29
description: Percentage of participants who died or went on mechanical ventilation from Day 6 through Day 29 based on high viral load mFAS were reported.
measure: Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on Seronegative mFAS
time frame: Day 6 to Day 29
description: Percentage of participants who died or went on mechanical ventilation from Day 6 through Day 29 based on seronegative mFAS were reported.
measure: Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on Overall mFAS
time frame: Day 6 to Day 29
description: Percentage of participants who died or went on mechanical ventilation from Day 6 through Day 29 based on overall FAS were reported.
measure: Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on High Viral Load mFAS
time frame: Day 1 to Day 29
description: Percentage of participants who died or went on mechanical ventilation from Day 1 through Day 29 based on high viral load mFAS were reported.
measure: Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on Seronegative mFAS
time frame: Day 1 to Day 29
description: Percentage of participants who died or went on mechanical ventilation from Day 1 through Day 29 based on seronegative mFAS were reported.
measure: Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on Overall mFAS
time frame: Day 1 to Day 29
description: Percentage of participants who died or went on mechanical ventilation from Day 1 through Day 29 based on overall mFAS were reported.
measure: Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Treatment-Emergent Serious Adverse Events
time frame: Up to Day 169
description: Treatment-emergent adverse events are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the observation period.
measure: Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Grade >=2 Infusion Related Reactions up to Day 4
time frame: Up to Day 4
description: Infusion-related reactions are defined as any relevant adverse event that occurs during the infusion or up to day 4. The severity of adverse events (including test findings classified as adverse events) were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).
measure: Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants With Grade >=2 Hypersensitivity Reactions Up to Day 29
time frame: Up to Day 29
description: Hypersensitivity reactions are defined as any relevant adverse event that occurs during the infusion or up to study day 29. The severity of adverse events (including test findings classified as adverse events) were graded according to NCI-CTCAE.
measure: Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Cumulative Incidence of Death or Mechanical Ventilation Based on Seronegative mFAS
time frame: Up to Day 29
description: Cumulative incidence percentage was estimated using Kaplan-Meier method.
measure: Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Cumulative Incidence of Death or Mechanical Ventilation Based on High Viral Load mFAS
time frame: Up to Day 29
description: Cumulative incidence percentage was estimated using Kaplan-Meier method.
measure: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on High Viral Load mFAS
time frame: by Day 29
description: Percentage of participants who went on mechanical ventilation by Day 29 based on High Viral Load mFAS in pooled analysis phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.
measure: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on Seronegative mFAS
time frame: by Day 29
description: Percentage of participants who went on mechanical ventilation at Day 29 based on Seronegative mFAS in pooled analysis phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.
measure: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on High Viral Load mFAS
time frame: Day 6 to Day 29
description: Percentage of participants who died from Day 6 through Day 29 based on high viral load mFAS were reported.
measure: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on Seronegative mFAS
time frame: Day 6 to Day 29
description: Percentage of participants who died from Day 6 through Day 29 Based on seronegative mFAS in pooled analysis phase 3 (cohort 1) and phase 2 (cohort 1A) were reported.
measure: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on High Viral Load mFAS
time frame: Day 1 to Day 29
description: Percentage of participants who died from Day 1 through Day 29 based on High Viral Load mFAS in pooled analysis phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported.
measure: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on Seronegative mFAS
time frame: Day 1 to Day 29
description: Percentage of participants who died from Day 1 through Day 29 based on seronegative mFAS in pooled analysis phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported.
measure: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on High Viral Load mFAS
time frame: by Day 29
description: Percentage of participants who were discharged by Day 29 based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported.
measure: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on Seronegative mFAS
time frame: by Day 29
description: Percentage of participants who were discharged by Day 29 based on seronegative mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported.
measure: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital Over Time Based on High Viral Load mFAS
time frame: Up to Day 29
description: Percentage of participants who died or were readmitted to hospital over time based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A)were reported. Readmission to hospital was based on investigator report.
measure: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital by Day 29 Based on Seronegative mFAS
time frame: by Day 29
description: Percentage of participants who died or were readmitted to hospital at Day 29 based on seronegative mFAS in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Readmission to hospital was based on investigator report.
measure: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death (ie, Overall Survival) by Day 29 Based on High Viral Load mFAS
time frame: by Day 29
description: Overall Survival was defined as time interval from randomization to death. Percentage of participants with cumulative incidence of death (ie, overall survival) at Day 29 from randomization based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.
measure: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death (ie, Overall Survival) by Day 29 Based on Seronegative mFAS
time frame: by Day 29
description: Overall Survival was defined as time interval from randomization to death. Percentage of participants with cumulative incidence of death (ie, overall survival) at Day 29 from randomization based on seronegative mFAS in phase 3 (Cohort 1) and phase 2 (Cohort 1A)were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.
measure: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on High Viral Load mFAS
time frame: by Day 29
description: Number of participants with cumulative incidence of mechanical ventilation by Day 29 based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.
measure: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on Seronegative mFAS
time frame: by Day 29
description: Percentage of participants with cumulative incidence of mechanical ventilation by Day 29 based on seronegative mFAS in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.
measure: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on High Viral Load mFAS
time frame: by Day 29
description: Percentage of participants with cumulative incidence of death or mechanical ventilation by Day 29 based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.
measure: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on Seronegative mFAS
time frame: by Day 29
description: Percentage of participants with cumulative incidence of death or mechanical ventilation by Day 29 based on seronegative mFAS in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.
measure: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on High Viral Load mFAS
time frame: Up to Day 56
description: Time to discharge from hospital based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) was reported.
measure: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on Seronegative mFAS
time frame: Up to Day 56
description: Time to discharge from hospital based on Seronegative mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) was reported.
measure: Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants With Treatment-Emergent Serious Adverse Events
time frame: Up to Day 169
measure: Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants With Grade >=2 Infusion Related Reactions up to Day 4
time frame: Up to Day 4
measure: Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants With Grade >=2 Hypersensitivity Reactions Up to Day 29
time frame: Up to Day 29
measure: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on Seronegative mFAS
time frame: by Day 29
description: Percentage of participants who went on mechanical ventilation in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.
measure: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on Seronegative mFAS
time frame: Day 6 to Day 29
description: Percentage of participants who died from Day 6 through Day 29 in phase 3 (cohort 1) and phase 2 (cohort 1A) were reported.
measure: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on Seronegative mFAS
time frame: Day 1 to Day 29
description: Percentage of participants who died from Day 1 through Day 29 in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported.
measure: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on Seronegative mFAS
time frame: by Day 29
description: Percentage of participants who were discharged in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) by Day 29 were reported.
measure: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital by Day 29 Based on Seronegative mFAS
time frame: Up to Day 29
description: Percentage of participants who died or were readmitted to hospital in phase 3 (Cohort 1) and phase 2 (Cohort 1A) by Day 29 were reported. Readmission to hospital was based on investigator report.
measure: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death up to Day 29 Based on Seronegative mFAS
time frame: Up to Day 29
description: Percentage of participants with cumulative incidence of death in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) up to Day 29 from randomization were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.
measure: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on Seronegative mFAS
time frame: by Day 29
description: Percentage of participants with cumulative incidence of mechanical ventilation in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) by Day 29 were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.
measure: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on Seronegative mFAS
time frame: by Day 29
description: Percentage of participants with cumulative incidence of death or mechanical ventilation in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) by Day 29 were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.
measure: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on Seronegative mFAS
time frame: Up to Day 56
description: Time to discharge from hospital up to Day 56 was reported.
measure: Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: TWA Change From Baseline Viral Load (Seronegative mFAS) in NP Samples up to Day 11 Based on Seronegative mFAS
time frame: Day 1 to Day 11
description: TWA change from baseline in viral load up to Day 11 was calculated for each participant using the trapezoidal rule as the area under the curve for change from baseline at each time point divided by the time interval for the observation period. TWA change from baseline viral load in NP samples through Day 11, was measured by RT-qPCR in NP swab samples was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicate improvement in viral load.
measure: Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: TWA Change From Baseline Viral Load (Seronegative mFAS) in NP Samples up to Day 29
time frame: Day 1 to Day 29
description: TWA change from baseline in viral load up to Day 29 was calculated for each participant using the trapezoidal rule as the area under the curve for change from baseline at each time point divided by the time interval for the observation period. TWA change from baseline viral load in NP samples through Day 29, was measured by quantitative RT-qPCR in NP swab samples was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicate improvement in viral load.
measure: Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time
time frame: Days 3, 5, 7, 9, 11, 13, 15, 22 and 29
description: Change from baseline in viral load as measured by RT-qPCR in NP swabs over time was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicates improvement in viral load.
measure: Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time
time frame: Days 3, 5, 7, 9, 11, 13, 15, 22 and 29
description: Percent change from baseline in viral load as measured by RT-qPCR in NP swabs over time was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicates improvement in viral load.
measure: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on High Viral Load mFAS
time frame: by Day 29
description: Percentage of participants who went on mechanical ventilation in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.
measure: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 to Day 29 Based on High Viral Load mFAS
time frame: Day 6 to Day 29
description: Percentage of participants who died in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.
measure: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 to Day 29 Based on High Viral Load mFAS
time frame: Day 1 to Day 29
description: Percentage of participants who died in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.
measure: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on High Viral Load mFAS
time frame: by Day 29
description: Percentage of participants who were discharged in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.
measure: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital Over Time Based on High Viral Load mFAS
time frame: Up to Day 29
description: Percentage of participants who died or were readmitted to hospital in phase 3 (Cohort 1) and phase 2 (Cohort 1A) over time were reported. Readmission to hospital was based on investigator report.
measure: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death Over Time Based on High Viral Load mFAS
time frame: Up to Day 29
description: Cumulative Incidence of Death Over Time in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.
measure: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation Over Time Based on High Viral Load mFAS
time frame: Up to Day 29
description: Cumulative Incidence of Mechanical Ventilation Over Time in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.
measure: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation Over Time Based on High Viral Load mFAS
time frame: Up to Day 29
description: Cumulative Incidence of Death or Mechanical Ventilation Over Time in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.
measure: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge Based on High Viral Load mFAS
time frame: Up to Day 56
description: Time to Discharge in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported.
measure: Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Over Time Based on Seronegative mFAS
time frame: Up to Day 29
description: Time-weighted average daily change over time up to Day 29 in viral load (log10 copies/mL), as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.
measure: Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Change From Baseline as Measured by RT-qPCR in NP Swabs Over Time Based on Seronegative mFAS
time frame: Days 3, 5, 7, 9, 11, 13, 15, 22 and 29
description: Change from baseline in viral load as measured by RT-qPCR in NP swabs over time was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicates improvement in viral load.
measure: Phase 1 [Cohort 1] and Phase 2 [Cohort 1]: Percentage of Participants Who Died or Went On Mechanical Ventilation by Day 29 Based on Seronegative mFAS
time frame: Through Day 29
measure: Phase 1 [Cohort 1] and Phase 2 [Cohort 1]: Percentage of Participants Who Died or Went On Mechanical Ventilation by Day 29 Based on High Viral Load mFAS
time frame: Through Day 29
measure: Phase 1 [Cohort 1]: Area Under the Concentration-Time Curve From Time 0 to 28 Days Post-dose (AUC0-28)
time frame: Up to Day 28
measure: Concentration at the End of Infusion (Ceoi)
time frame: Day 1
measure: Concentration at Day 28 (C28)
time frame: Day 28
measure: Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933
time frame: Through Day 169
measure: Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987
time frame: Through Day 169
measure: Immunogenicity as Measured by Neutralizing Antibody Status (NAb) to REGN10933
time frame: Through Day 57
measure: Immunogenicity as Measured by Neutralizing Antibody Status (NAb) to REGN10987
time frame: Through Day 57
arm group label: On Low-Flow Oxygen
arm group type: Experimental
description: Cohort 1 (C1): O2 saturation >93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device
arm group label: With COVID-19 symptoms but not requiring supplemental O2
arm group type: Experimental
description: Cohort 1A (C1A): With COVID-19 symptoms but not requiring supplemental oxygen
arm group label: High O2 No Mechanical Ventilation
arm group type: Experimental
description: Cohort 2 (C2): On high-intensity oxygen (O2) therapy but not on mechanical ventilation
arm group label: On Mechanical Ventilation
arm group type: Experimental
description: Cohort 3 (C3): On mechanical ventilation
intervention type: Drug
intervention name: REGN10933+REGN10987 combination therapy
description: Administered intravenously (IV) single dose
arm group label: High O2 No Mechanical Ventilation
arm group label: On Low-Flow Oxygen
arm group label: On Mechanical Ventilation
arm group label: With COVID-19 symptoms but not requiring supplemental O2
other name: REGN-COV2
other name: REGEN-COV™
other name: Ronapreve™
other name: casirivimab
other name: imdevimab
intervention type: Drug
intervention name: Placebo
description: Placebo IV Single Dose
arm group label: High O2 No Mechanical Ventilation
arm group label: On Low-Flow Oxygen
arm group label: On Mechanical Ventilation
arm group label: With COVID-19 symptoms but not requiring supplemental O2
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trial Management
role: Study Director
affiliation: Regeneron Pharmaceuticals
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country: Brazil
country: Chile
country: Mexico
country: Moldova, Republic of
country: Romania
country: United States
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Casirivimab and imdevimab drug combination
sharing ipd: Yes
ipd description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification
ipd access criteria: Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).
ipd url: https://vivli.org/
provided document: 
provided document: 
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point of contact: 