<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/NCT04452318</url>
  </required_header>
  <id_info>
    <org_study_id>R10933-10987-COV-2069</org_study_id>
    <secondary_id>2020-003654-71</secondary_id>
    <nct_id>NCT04452318</nct_id>
  </id_info>
  <brief_title>COVID-19 Study Assessing the Efficacy and Safety of Anti-Spike SARS CoV-2 Monoclonal Antibodies for Prevention of SARS CoV-2 Infection Asymptomatic in Healthy Adults and Adolescents Who Are Household Contacts to an Individual With a Positive SARS-CoV-2 RT-PCR Assay</brief_title>
  <official_title>A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy and Safety of Anti-Spike SARS-CoV-2 Monoclonal Antibodies in Preventing SARS-CoV-2 Infection in Household Contacts of Individuals Infected With SARS-CoV-2</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>
      Primary Objectives:&#xD;
&#xD;
      Cohort A:&#xD;
&#xD;
      • To evaluate the efficacy of REGN10933+REGN10987 compared to placebo in preventing&#xD;
      symptomatic SARS-CoV-2 infection (broad-term) confirmed by RT-qPCR&#xD;
&#xD;
      Cohort A and Cohort A1:&#xD;
&#xD;
      • To evaluate the safety and tolerability of REGN10933+REGN10987 following subcutaneous (SC)&#xD;
      administration compared to placebo&#xD;
&#xD;
      Cohort B • To evaluate the efficacy of REGN10933+REGN10987 compared to placebo in preventing&#xD;
      COVID-19 symptoms (broad-term)&#xD;
&#xD;
      Cohort B and Cohort B1&#xD;
&#xD;
      • To evaluate the safety and tolerability of REGN10933+REGN10987 following SC administration&#xD;
      compared to placebo&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cohort A: adult and adolescent subjects (≥12 years) who are SARS -CoV-2 RT-qPCR negative at&#xD;
      baseline&#xD;
&#xD;
      Cohort A1: pediatric subjects (&lt;12 years) who are SARS-CoV-2 RT--qPCR negative at baseline&#xD;
&#xD;
      Cohort B: adult and adolescent subjects (≥12 years) who are SARS -CoV-2 RT-qPCR positive at&#xD;
      baseline&#xD;
&#xD;
      Cohort B1: pediatric subjects (&lt;12 years) who are SARS-CoV-2 RT--qPCR positive at baseline&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 13, 2020</start_date>
  <completion_date type="Actual">October 4, 2021</completion_date>
  <primary_completion_date type="Actual">October 4, 2021</primary_completion_date>
  <phase>Phase 3</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad-term) During the EAP</measure>
    <time_frame>Up to 1 month</time_frame>
    <description>Symptomatic SARS-CoV-2 infection (broad-term) is defined as a positive central lab SARS-CoV-2 RT-qPCR result (either NP, nasal or saliva) associated with signs and symptoms with the onset date occurring within 14 days of a positive RT-qPCR during the EAP. Percentage estimated by Logistic Regression.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cohort B: Percentage of Participants Who Subsequently Develop Signs and Symptoms (Broad-Term) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP</measure>
    <time_frame>Up to 14 Days</time_frame>
    <description>The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:&gt;=12 to=50), and region (US vs ex-US).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cohort A and Cohort B: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAEs) and Severity of TEAEs</measure>
    <time_frame>Up to 8 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cohort A and Cohort B: Percentage of Participants With High Viral Load in Nasopharyngeal (NP) Swab Samples During the EAP</measure>
    <time_frame>Up to 1 month</time_frame>
    <description>High viral load (&gt; 4 log 10 copies/ml)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort A: Number of Weeks of Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad Term) During the EAP</measure>
    <time_frame>Up to 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort A and Cohort B: Number of Weeks of High Viral Load in NP Swab Samples During the EAP</measure>
    <time_frame>Up to 1 month</time_frame>
    <description>High viral load (&gt; 4 log 10 copies/ml)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort A: Number of Weeks of RT-qPCR Confirmed SARS-CoV-2 Infection (Regardless of Symptoms) During the EAP</measure>
    <time_frame>Up to 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort A: Percentage of Participants Who Have a RT-qPCR Confirmed SARS-CoV-2 Infection (Regardless of Symptoms) During the EAP</measure>
    <time_frame>Up to 1 month</time_frame>
    <description>The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:&gt;=12 to=50), and region (US vs ex-US)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort A: Percentage of Participants in Placebo Group With a RT-qPCR Confirmed SARS-CoV-2 Infection During the EAP With an Index Case Participating in Study R10933-10987-COV-2067 (NCT04425629)</measure>
    <time_frame>Up to 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort A: Percentage of Participants With a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (CDC Definition) During the EAP</measure>
    <time_frame>Up to 1 month</time_frame>
    <description>Symptomatic SARS-CoV-2 infection (CDC definition) is defined as a positive central lab SARS-CoV-2 RT-qPCR result (either NP, nasal or saliva) associated with signs and symptoms with the onset date occurring within 14 days of a positive RT-qPCR during the EAP. Percentage estimated by Logistic Regression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort A: Number of Weeks of Symptomatic RT-qPCR-confirmed SARS-CoV-2 Infection (CDC Definition) During the EAP</measure>
    <time_frame>Up to 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Strict-term) During the EAP</measure>
    <time_frame>Up to 1 month</time_frame>
    <description>The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:&gt;=12 to=50), and region (US vs ex-US)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort A: Number of Weeks of Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Strict-term) During the EAP</measure>
    <time_frame>Up to 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort A: Percentage of Participants Who Have a RT-qPCR Confirmed SARS-CoV-2 Infections at Each Week in the EAP</measure>
    <time_frame>Week 1, Week 2, Week 3, Week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad-term) at Each Week in the EAP</measure>
    <time_frame>Week 1, Week 2, Week 3, Week 4</time_frame>
    <description>The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:&gt;=12 to=50), and region (US vs ex-US)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort A: Time-weighted Average of Viral Load From the First Positive SARS CoV-2 RT-qPCR in NP Swab Samples (That Has an Onset During the EAP) Until the Third Weekly Visit After the First Positive Test During the EAP</measure>
    <time_frame>Up to 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort A: Time-weighted Average of Viral Load From the First Positive SARS-CoV-2 RT-qPCR in NP Swab Samples (That Has an Onset During the EAP) Until the Second Weekly Visit After the First Positive Test During the EAP</measure>
    <time_frame>Up to 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort A: Maximum SARS-CoV-2 RT-qPCR Viral Load in NP Swab Samples Among Individuals With ≥1 RT-qPCR Positive That Has an Onset During the EAP</measure>
    <time_frame>Up to 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort A: SARS-CoV-2 RT-qPCR Viral Load in NP Swab Samples Corresponding to the Onset of First Positive RT-qPCR During the EAP</measure>
    <time_frame>Up to 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort A: Area Under the Curve (AUC) in Viral Load From the First Positive SARS-CoV-2 RT-qPCR NP Swab Samples Detected During the EAP Until the First Confirmed Negative Test</measure>
    <time_frame>Up to 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort A: Total Number of Medically Attended Visits in Emergency Rooms or Urgent Care Centers Related to a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset During the EAP</measure>
    <time_frame>Up to 1 month</time_frame>
    <description>Medically attended visits referred to hospitalizations, Emergency Room visits, or visits at an Urgent Care center.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort A: Percentage of Participants With at Least 1 COVID-19-related Hospitalization or Emergency Room Visit Associated With a Positive RT-qPCR During the EAP or All-cause Death</measure>
    <time_frame>Up to 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort A: Percentage of Participants Requiring Medically Attended Visits in Emergency Rooms or Urgent Care Centers Related to a RT-qPCR Confirmed SARS CoV-2 Infection That Has an Onset During the EAP</measure>
    <time_frame>Up to 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort A: Proportion of Participants Hospitalized Related to a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset During the EAP</measure>
    <time_frame>Up to 14 Days</time_frame>
    <description>The proportion of participants hospitalized related to a RT-qPCR confirmed SARS-CoV-2 infection that has an onset during the EAP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort A: Number of Days of Hospital and Intensive Care Unit (ICU) Stay in Participants Hospitalized for a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset During the EAP</measure>
    <time_frame>Up to Day 29</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort A: Number of Days Missed for Daily Responsibilities Due to a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset During the EAP</measure>
    <time_frame>Up to 1 month</time_frame>
    <description>Daily responsibilities including work (employed adults) or school (students), daycare or family obligations/responsibilities (childcare or eldercare)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort A: Proportion of Baseline Seropositive Participants (Based on Central Lab Test) With TEAEs and Severity of TEAEs</measure>
    <time_frame>Up to 8 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the EAP</measure>
    <time_frame>Up to Day 29</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the Follow-Up Period</measure>
    <time_frame>Day 30 Up to Day 225 (Approximately 8 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the EAP</measure>
    <time_frame>Up to Day 29</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the Follow-Up Period</measure>
    <time_frame>Day 30 Up to Day 225 (Approximately 8 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the EAP</measure>
    <time_frame>Up to Day 29</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the Follow-Up Period</measure>
    <time_frame>Day 30 Up to Day 225 (Approximately 8 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort B: Number of Weeks of Symptomatic SARS-CoV-2 Infection (Broad-term) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP</measure>
    <time_frame>Up to 14 Days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort B: Percentage of Participants With Asymptomatic Infection Who Develop Signs and Symptoms (CDC Definition) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP</measure>
    <time_frame>Up to 1 month</time_frame>
    <description>The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:&gt;=12 to=50), and region (US vs ex-US)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort B: Percentage of Participants Who Subsequently Develop Signs and Symptoms (Strict-term) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP</measure>
    <time_frame>Up to 14 Days</time_frame>
    <description>The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:&gt;=12 to=50), and region (US vs ex-US)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort B: Number of Weeks of Symptomatic SARS-CoV-2 Infection (CDC Definition) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP</measure>
    <time_frame>Up to 14 Days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort B: Number of Weeks of Symptomatic SARS-CoV-2 Infection (Strict-term Definition) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP</measure>
    <time_frame>Up to 14 Days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort B: Change in Viral Load From Baseline to Day 8 Visit in NP Swab Samples</measure>
    <time_frame>Up to day 8 visit</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort B: Change in Viral Load From Baseline to Day 15 Visit in NP Swab Samples</measure>
    <time_frame>Up to day 15 visit</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort B: Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL) in NP Swab Samples Until the Day 22 Visit</measure>
    <time_frame>Day 22</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort B: AUC in Viral Load From the First Positive SARS-CoV-2 RT-qPCR NP Swab Samples Detected During the EAP to the First Confirmed Negative Test</measure>
    <time_frame>Up to 14 Days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort B: Maximum SARS-CoV-2 RT-qPCR Viral Load in NP Swab Samples in Participants With 1 or More Positive Test That Has an Onset During the EAP</measure>
    <time_frame>Up to 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort B: Number of Medically Attended Visits in Emergency Rooms or Urgent Care Centers Related to RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset at Baseline or During the EAP</measure>
    <time_frame>Up to 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort B: Percentage of Participants Requiring Medically Attended Visits in Emergency Rooms or Urgent Care Centers Related to a RT-qPCR Confirmed SARS CoV-2 Infection That Has an Onset at Baseline or During the EAP</measure>
    <time_frame>Up to 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort B: Percentage of Participants Hospitalized Related to a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset at Baseline or During the EAP</measure>
    <time_frame>Up to 14 Days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort B: Number of Days Missed for Daily Responsibilities (Where Applicable) Due to a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset at Baseline or During the EAP</measure>
    <time_frame>Up to 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort B: Number of Days of Hospital and Intensive Care Unit (ICU) Stay in Participants Hospitalized for a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset at Baseline or During the EAP</measure>
    <time_frame>Up to 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentrations of REGN10987 in Serum Over Time (Cohort A)</measure>
    <time_frame>0 Days Post-Dose, 28 Days Post-Dose, 56 Days Post-Dose, 112 Days Post-Dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentrations of REGN10987 in Serum Over Time (Cohort B)</measure>
    <time_frame>0 Days Post-Dose, 28 Days Post-Dose, 56 Days Post-Dose, 112 Days Post-Dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentrations of REGN10933 in Serum Over Time (Cohort A)</measure>
    <time_frame>0 Days Post-Dose, 28 Days Post-Dose, 56 Days Post-Dose, 112 Days Post-Dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentrations of REGN10933 in Serum Over Time (Cohort B)</measure>
    <time_frame>0 Days Post-Dose, 28 Days Post-Dose, 56 Days Post-Dose, 112 Days Post-Dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933</measure>
    <time_frame>Up to 8 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987</measure>
    <time_frame>Up to 8 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10933</measure>
    <time_frame>Up to 8 months</time_frame>
    <description>(TE&amp;TB+;NAb+) = TE = Treatment-Emergent; TB = Treatment-boosted; NAb+ = Positive in NAb assay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987</measure>
    <time_frame>Up to 8 Months</time_frame>
    <description>(TE&amp;TB+;NAb+) = TE = Treatment-emergent; TB = Treatment-boosted; NAb+ = Positive in NAb assay</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">3303</enrollment>
  <condition>Healthy Participants</condition>
  <arm_group>
    <arm_group_label>REGN10933 + REGN10987</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>REGN10933 + REGN10987</intervention_name>
    <description>Subcutaneous (SC) or Intramuscular (IM) injections</description>
    <arm_group_label>REGN10933 + REGN10987</arm_group_label>
    <other_name>REGN-COV2</other_name>
    <other_name>Casirivimab</other_name>
    <other_name>Imdevimab</other_name>
    <other_name>REGEN-COV™</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>SC or IM injections</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          1. Adult subjects 18 years of age (irrespective of weight) and above at the signing of&#xD;
             informed consent or adolescent participants ≥12 to &lt;18 years of age, or pediatric&#xD;
             participants &lt;12 years of age at the signing of the assent (parent/guardian sign the&#xD;
             informed consent)&#xD;
&#xD;
          2. Asymptomatic household contact with exposure to an individual with a diagnosis of&#xD;
             SARS-CoV-2 infection (index case). To be included in the study, participants must be&#xD;
             randomized within 96 hours of collection of the index cases' positive SARS-COV-2&#xD;
             diagnostic test sample&#xD;
&#xD;
          3. Participant anticipates living in the same household with the index case until study&#xD;
             day 29&#xD;
&#xD;
          4. Is judged by the investigator to be in good health based on medical history and&#xD;
             physical examination at screening/baseline, including participants who are healthy or&#xD;
             have a chronic, stable medical condition&#xD;
&#xD;
          5. Willing and able to comply with study visits and study-related procedures/assessments.&#xD;
&#xD;
          6. Provide informed consent signed by study participant or legally acceptable&#xD;
             representative.&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          1. History of prior positive SARS-CoV-2 RT-PCR test or positive SARS-CoV-2 serology test&#xD;
             at any time before the screening&#xD;
&#xD;
          2. Participant has lived with individuals who have had previous SARS-CoV-2 infection or&#xD;
             currently lives with individuals who have SARS-CoV-2 infection, with the exception of&#xD;
             the index case(s), the first individual(s) known to be infected in the household&#xD;
&#xD;
          3. Active respiratory or non-respiratory symptoms consistent with COVID-19&#xD;
&#xD;
          4. History of respiratory illness with sign/symptoms of SARS-CoV-2 infection, in the&#xD;
             opinion of the investigator, within the prior 6 months to screening&#xD;
&#xD;
          5. Nursing home resident&#xD;
&#xD;
          6. Any physical examination findings, and/or history of any illness, concomitant&#xD;
             medications or recent live vaccines that, in the opinion of the study investigator,&#xD;
             might confound the results of the study or pose an additional risk to the participant&#xD;
             by their participation in the study&#xD;
&#xD;
        Note: Other protocol-defined Inclusion/ Exclusion criteria apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</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>Mesa</city>
        <state>Arizona</state>
        <zip>85210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</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>La Mesa</city>
        <state>California</state>
        <zip>91942</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>La Palma</city>
        <state>California</state>
        <zip>90623</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>Los Angeles</city>
        <state>California</state>
        <zip>90035</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90036</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Montclair</city>
        <state>California</state>
        <zip>91763</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Northridge</city>
        <state>California</state>
        <zip>91324</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Oxnard</city>
        <state>California</state>
        <zip>93030</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>Sacramento</city>
        <state>California</state>
        <zip>95821</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94127</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>Torrance</city>
        <state>California</state>
        <zip>90502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90505</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>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80907</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20005</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33487</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>DeLand</city>
        <state>Florida</state>
        <zip>32720</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>Hialeah</city>
        <state>Florida</state>
        <zip>33010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Lakeland</city>
        <state>Florida</state>
        <zip>33810</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Loxahatchee Groves</city>
        <state>Florida</state>
        <zip>33470</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Maitland</city>
        <state>Florida</state>
        <zip>32751</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33125</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33126</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33184</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33186</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>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>West Palm Beach</city>
        <state>Florida</state>
        <zip>33407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Winter Park</city>
        <state>Florida</state>
        <zip>32789</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30303</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>Columbus</city>
        <state>Georgia</state>
        <zip>31904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
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        <state>Georgia</state>
        <zip>30030</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Eatonton</city>
        <state>Georgia</state>
        <zip>31024</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>Sandy Springs</city>
        <state>Georgia</state>
        <zip>30328</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site 2</name>
      <address>
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        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site 3</name>
      <address>
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        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
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        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site 1</name>
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        <zip>60515</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site 2</name>
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        <state>Illinois</state>
        <zip>60515</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Ames</city>
        <state>Iowa</state>
        <zip>50010-3014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Lake Charles</city>
        <state>Louisiana</state>
        <zip>70601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Marrero</city>
        <state>Louisiana</state>
        <zip>70072</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Metairie</city>
        <state>Louisiana</state>
        <zip>70006</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>
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        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
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    </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>02114</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>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
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        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
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        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Gulfport</city>
        <state>Mississippi</state>
        <zip>39503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Hazelwood</city>
        <state>Missouri</state>
        <zip>63042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
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        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
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        <state>Nevada</state>
        <zip>89104</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
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        <state>Nevada</state>
        <zip>89109</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Morristown</city>
        <state>New Jersey</state>
        <zip>07960</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Newark</city>
        <state>New Jersey</state>
        <zip>07103</zip>
        <country>United States</country>
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    </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>07666-4245</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site 1</name>
      <address>
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        <state>New York</state>
        <zip>10451</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site 2</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10451</zip>
        <country>United States</country>
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    </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>Buffalo</city>
        <state>New York</state>
        <zip>14203</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>10016</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>10027</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>New York</city>
        <state>New York</state>
        <zip>10065</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>Charlotte</city>
        <state>North Carolina</state>
        <zip>28209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Fayetteville</city>
        <state>North Carolina</state>
        <zip>28304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Wilmington</city>
        <state>North Carolina</state>
        <zip>28401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45267-0405</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>45432</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Danville</city>
        <state>Pennsylvania</state>
        <zip>17822</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</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>Wilkes-Barre</city>
        <state>Pennsylvania</state>
        <zip>18711</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>Charleston</city>
        <state>South Carolina</state>
        <zip>29406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Clinton</city>
        <state>South Carolina</state>
        <zip>29325</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Gaffney</city>
        <state>South Carolina</state>
        <zip>29340</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>57105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37421</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37920</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Bellaire</city>
        <state>Texas</state>
        <zip>77401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Corpus Christi</city>
        <state>Texas</state>
        <zip>78413</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77008</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>77026</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Pearland</city>
        <state>Texas</state>
        <zip>77584</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Red Oak</city>
        <state>Texas</state>
        <zip>75154</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78249</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>Charlottesville</city>
        <state>Virginia</state>
        <zip>22903</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</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Yakima</city>
        <state>Washington</state>
        <zip>98902</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>Chisinau</city>
        <zip>MD-2025</zip>
        <country>Moldova, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Bucharest</city>
        <zip>021105</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Moldova, Republic of</country>
    <country>Romania</country>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <results_first_submitted>September 29, 2022</results_first_submitted>
  <results_first_submitted_qc>April 20, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">May 15, 2023</results_first_posted>
  <last_update_submitted>April 20, 2023</last_update_submitted>
  <last_update_submitted_qc>April 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Asymptomatic</keyword>
  <keyword>Individuals at risk of exposure to SARS-CoV-2</keyword>
  <keyword>Household Contacts of a Person Infected with SARS-CoV-2</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., 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>March 25, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/18/NCT04452318/Prot_001.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>March 26, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/18/NCT04452318/SAP_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 22, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/18/NCT04452318/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Of 3375 participants screened, 3298 participants were randomized and 3270 participants were treated. 77 participants were screen failures and 28 participants were randomized but not treated.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Cohort A: Placebo of R10933 + R10987</title>
          <description>Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
        </group>
        <group group_id="P2">
          <title>R10933 + R10987</title>
          <description>R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
        </group>
        <group group_id="P3">
          <title>Cohort A1: Placebo of R10933 + R10987</title>
          <description>Cohort A1: Placebo of R10933 + R10987 Pediatric Subjects (&lt;12 years) with SARS-CoV-2 RT-qPCR Negative</description>
        </group>
        <group group_id="P4">
          <title>Cohort B: Placebo of R10933 + R10987</title>
          <description>Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive</description>
        </group>
        <group group_id="P5">
          <title>Cohort B: R10933 + R10987</title>
          <description>Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive</description>
        </group>
        <group group_id="P6">
          <title>Undetermined: Placebo of R10933 + R10987</title>
          <description>Undetermined: Placebo of R10933 + R10987 Adult and Adolescent subjects (≥12 years) whose baseline RT-qPCR status was inconclusive or missing</description>
        </group>
        <group group_id="P7">
          <title>Undetermined: R10933 + R10987</title>
          <description>Undetermined: R10933 + R10987 Adult and Adolescent subjects (≥12 years) whose baseline RT-qPCR status was inconclusive or missing</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1430"/>
                <participants group_id="P2" count="1441"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="173"/>
                <participants group_id="P5" count="166"/>
                <participants group_id="P6" count="53"/>
                <participants group_id="P7" count="34"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Randomized and Treated</title>
              <participants_list>
                <participants group_id="P1" count="1428"/>
                <participants group_id="P2" count="1439"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="170"/>
                <participants group_id="P5" count="165"/>
                <participants group_id="P6" count="44"/>
                <participants group_id="P7" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1343"/>
                <participants group_id="P2" count="1368"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="150"/>
                <participants group_id="P5" count="157"/>
                <participants group_id="P6" count="41"/>
                <participants group_id="P7" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="87"/>
                <participants group_id="P2" count="73"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="23"/>
                <participants group_id="P5" count="9"/>
                <participants group_id="P6" count="12"/>
                <participants group_id="P7" count="12"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
                <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_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
                <participants group_id="P2" count="28"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="46"/>
                <participants group_id="P2" count="40"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="18"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="8"/>
                <participants group_id="P7" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Cohort A: Placebo of R10933 + R10987</title>
          <description>Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
        </group>
        <group group_id="B2">
          <title>R10933 + R10987</title>
          <description>R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
        </group>
        <group group_id="B3">
          <title>Cohort A1: Placebo of R10933 + R10987</title>
          <description>Cohort A1: Placebo of R10933 + R10987 Pediatric Subjects (&lt;12 years) with SARS-CoV-2 RT-qPCR Negative</description>
        </group>
        <group group_id="B4">
          <title>Cohort B: Placebo of R10933 + R10987</title>
          <description>Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive</description>
        </group>
        <group group_id="B5">
          <title>Cohort B: R10933 + R10987</title>
          <description>Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive</description>
        </group>
        <group group_id="B6">
          <title>Undetermined: Placebo of R10933 + R10987</title>
          <description>Undetermined: Placebo of R10933 + R10987 Adult and Adolescent subjects (≥12 years) whose baseline RT-qPCR status was inconclusive or missing</description>
        </group>
        <group group_id="B7">
          <title>Undetermined: R10933 + R10987</title>
          <description>Undetermined: R10933 + R10987 Adult and Adolescent subjects (≥12 years) whose baseline RT-qPCR status was inconclusive or missing</description>
        </group>
        <group group_id="B8">
          <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="1430"/>
            <count group_id="B2" value="1441"/>
            <count group_id="B3" value="1"/>
            <count group_id="B4" value="173"/>
            <count group_id="B5" value="166"/>
            <count group_id="B6" value="53"/>
            <count group_id="B7" value="34"/>
            <count group_id="B8" value="3298"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42.4" spread="15.70"/>
                    <measurement group_id="B2" value="42.1" spread="16.00"/>
                    <measurement group_id="B3" value="10.0" spread="0.0"/>
                    <measurement group_id="B4" value="41.8" spread="18.1"/>
                    <measurement group_id="B5" value="39.5" spread="17.81"/>
                    <measurement group_id="B6" value="43.0" spread="16.73"/>
                    <measurement group_id="B7" value="39.0" spread="15.3"/>
                    <measurement group_id="B8" value="42.0" spread="16.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>In utero</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_list>
                </category>
                <category>
                  <title>Preterm newborn infants (gestational age &lt; 37 wks)</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_list>
                </category>
                <category>
                  <title>Newborns (0-27 days)</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_list>
                </category>
                <category>
                  <title>Infants and toddlers (28 days-23 months)</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_list>
                </category>
                <category>
                  <title>Children (2-11 years)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <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="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Adolescents (12-17 years)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                    <measurement group_id="B2" value="52"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="20"/>
                    <measurement group_id="B5" value="23"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="145"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Adults (18-64 years)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1272"/>
                    <measurement group_id="B2" value="1263"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="130"/>
                    <measurement group_id="B5" value="127"/>
                    <measurement group_id="B6" value="45"/>
                    <measurement group_id="B7" value="30"/>
                    <measurement group_id="B8" value="2867"/>
                  </measurement_list>
                </category>
                <category>
                  <title>From 65-84 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="105"/>
                    <measurement group_id="B2" value="125"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="21"/>
                    <measurement group_id="B5" value="15"/>
                    <measurement group_id="B6" value="5"/>
                    <measurement group_id="B7" value="3"/>
                    <measurement group_id="B8" value="274"/>
                  </measurement_list>
                </category>
                <category>
                  <title>85 years and over</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="1"/>
                    <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="11"/>
                  </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="738"/>
                    <measurement group_id="B2" value="780"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="97"/>
                    <measurement group_id="B5" value="80"/>
                    <measurement group_id="B6" value="21"/>
                    <measurement group_id="B7" value="20"/>
                    <measurement group_id="B8" value="1736"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="692"/>
                    <measurement group_id="B2" value="661"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="76"/>
                    <measurement group_id="B5" value="86"/>
                    <measurement group_id="B6" value="32"/>
                    <measurement group_id="B7" value="14"/>
                    <measurement group_id="B8" value="1562"/>
                  </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="707"/>
                    <measurement group_id="B2" value="698"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="66"/>
                    <measurement group_id="B5" value="69"/>
                    <measurement group_id="B6" value="23"/>
                    <measurement group_id="B7" value="9"/>
                    <measurement group_id="B8" value="1573"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="711"/>
                    <measurement group_id="B2" value="735"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="105"/>
                    <measurement group_id="B5" value="96"/>
                    <measurement group_id="B6" value="30"/>
                    <measurement group_id="B7" value="25"/>
                    <measurement group_id="B8" value="1702"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1193"/>
                    <measurement group_id="B2" value="1196"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="149"/>
                    <measurement group_id="B5" value="140"/>
                    <measurement group_id="B6" value="46"/>
                    <measurement group_id="B7" value="29"/>
                    <measurement group_id="B8" value="2754"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="161"/>
                    <measurement group_id="B2" value="164"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="11"/>
                    <measurement group_id="B5" value="9"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="350"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="11"/>
                    <measurement group_id="B6" value="3"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="103"/>
                  </measurement_list>
                </category>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <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="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad-term) During the EAP</title>
        <description>Symptomatic SARS-CoV-2 infection (broad-term) is defined as a positive central lab SARS-CoV-2 RT-qPCR result (either NP, nasal or saliva) associated with signs and symptoms with the onset date occurring within 14 days of a positive RT-qPCR during the EAP. Percentage estimated by Logistic Regression.</description>
        <time_frame>Up to 1 month</time_frame>
        <population>Seronegative modified full analysis set in Cohort A includes randomized subjects aged 12 years and older who are laboratory confirmed negative for SARS-CoV-2 and negative serostatus for SAS-CoV-2 antibodies at baseline</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Placebo of R10933 + R10987</title>
            <description>Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
          <group group_id="O2">
            <title>Cohort A: R10933 + R10987</title>
            <description>Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad-term) During the EAP</title>
          <description>Symptomatic SARS-CoV-2 infection (broad-term) is defined as a positive central lab SARS-CoV-2 RT-qPCR result (either NP, nasal or saliva) associated with signs and symptoms with the onset date occurring within 14 days of a positive RT-qPCR during the EAP. Percentage estimated by Logistic Regression.</description>
          <population>Seronegative modified full analysis set in Cohort A includes randomized subjects aged 12 years and older who are laboratory confirmed negative for SARS-CoV-2 and negative serostatus for SAS-CoV-2 antibodies at baseline</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="752"/>
                <count group_id="O2" value="753"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.8"/>
                    <measurement group_id="O2" value="1.4"/>
                  </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>&lt; 0.0001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.17</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.090</ci_lower_limit>
            <ci_upper_limit>0.332</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cohort B: Percentage of Participants Who Subsequently Develop Signs and Symptoms (Broad-Term) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP</title>
        <description>The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:&gt;=12 to=50), and region (US vs ex-US).</description>
        <time_frame>Up to 14 Days</time_frame>
        <population>Estimate of percent of participants meeting the criteria based on fixed categories</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort B: Placebo of R10933 + R10987</title>
            <description>Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: R10933 + R10987</title>
            <description>Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort B: Percentage of Participants Who Subsequently Develop Signs and Symptoms (Broad-Term) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP</title>
          <description>The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:&gt;=12 to=50), and region (US vs ex-US).</description>
          <population>Estimate of percent of participants meeting the criteria based on fixed categories</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="104"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.5"/>
                    <measurement group_id="O2" value="28.4"/>
                  </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>= 0.0380</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.54</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.298</ci_lower_limit>
            <ci_upper_limit>0.966</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cohort A and Cohort B: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAEs) and Severity of TEAEs</title>
        <time_frame>Up to 8 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Placebo of R10933 + R10987</title>
            <description>Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
          <group group_id="O2">
            <title>Cohort A: R10933 + R10987</title>
            <description>Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
          <group group_id="O3">
            <title>Cohort B: Placebo of R10933 + R10987</title>
            <description>Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive</description>
          </group>
          <group group_id="O4">
            <title>Cohort B: R10933 + R10987</title>
            <description>Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort A and Cohort B: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAEs) and Severity of TEAEs</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1428"/>
                <count group_id="O2" value="1439"/>
                <count group_id="O3" value="170"/>
                <count group_id="O4" value="165"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title># of participants with at least one TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="512"/>
                    <measurement group_id="O2" value="405"/>
                    <measurement group_id="O3" value="88"/>
                    <measurement group_id="O4" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title># of participants with at least one Grade 1 TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="384"/>
                    <measurement group_id="O2" value="284"/>
                    <measurement group_id="O3" value="61"/>
                    <measurement group_id="O4" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title># of participants with at least one Grade 2 TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98"/>
                    <measurement group_id="O2" value="95"/>
                    <measurement group_id="O3" value="21"/>
                    <measurement group_id="O4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title># of participants with at least one Grade 3 TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="21"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title># of participants with at least one Grade 4 TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title># of participants with at least one Grade 5 TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort A and Cohort B: Percentage of Participants With High Viral Load in Nasopharyngeal (NP) Swab Samples During the EAP</title>
        <description>High viral load (&gt; 4 log 10 copies/ml)</description>
        <time_frame>Up to 1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Placebo of R10933 + R10987</title>
            <description>Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
          <group group_id="O2">
            <title>Cohort A: R10933 + R10987</title>
            <description>Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
          <group group_id="O3">
            <title>Cohort B: Placebo of R10933 + R10987</title>
            <description>Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive</description>
          </group>
          <group group_id="O4">
            <title>Cohort B: R10933 + R10987</title>
            <description>Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort A and Cohort B: Percentage of Participants With High Viral Load in Nasopharyngeal (NP) Swab Samples During the EAP</title>
          <description>High viral load (&gt; 4 log 10 copies/ml)</description>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="749"/>
                <count group_id="O2" value="745"/>
                <count group_id="O3" value="101"/>
                <count group_id="O4" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.3"/>
                    <measurement group_id="O2" value="1.6"/>
                    <measurement group_id="O3" value="62.6"/>
                    <measurement group_id="O4" value="40.5"/>
                  </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>&lt; 0.0001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.13</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.069</ci_lower_limit>
            <ci_upper_limit>0.236</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>= 0.0024</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.41</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.228</ci_lower_limit>
            <ci_upper_limit>0.728</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort A: Number of Weeks of Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad Term) During the EAP</title>
        <time_frame>Up to 1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Placebo of R10933 + R10987</title>
            <description>Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
          <group group_id="O2">
            <title>Cohort A: R10933 + R10987</title>
            <description>Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort A: Number of Weeks of Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad Term) During the EAP</title>
          <units>weeks</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="752"/>
                <count group_id="O2" value="753"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.25" spread="1.135" lower_limit="1.135"/>
                    <measurement group_id="O2" value="0.02" spread="0.181" lower_limit="0.181"/>
                  </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>&lt; 0.0001</p_value>
            <method>Stratified Wilcoxon Rank Sum Test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort A and Cohort B: Number of Weeks of High Viral Load in NP Swab Samples During the EAP</title>
        <description>High viral load (&gt; 4 log 10 copies/ml)</description>
        <time_frame>Up to 1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Placebo of R10933 + R10987</title>
            <description>Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
          <group group_id="O2">
            <title>Cohort A: R10933 + R10987</title>
            <description>Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
          <group group_id="O3">
            <title>Cohort B: Placebo of R10933 + R10987</title>
            <description>Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive</description>
          </group>
          <group group_id="O4">
            <title>Cohort B: R10933 + R10987</title>
            <description>Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort A and Cohort B: Number of Weeks of High Viral Load in NP Swab Samples During the EAP</title>
          <description>High viral load (&gt; 4 log 10 copies/ml)</description>
          <units>weeks</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="749"/>
                <count group_id="O2" value="745"/>
                <count group_id="O3" value="101"/>
                <count group_id="O4" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.18" spread="0.554" lower_limit="0.554"/>
                    <measurement group_id="O2" value="0.02" spread="0.154" lower_limit="0.154"/>
                    <measurement group_id="O3" value="0.81" spread="0.758" lower_limit="0.758"/>
                    <measurement group_id="O4" value="0.49" spread="0.677" lower_limit="0.677"/>
                  </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>&lt; 0.0001</p_value>
            <method>Stratified Wilcoxon Rank Sum Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>= 0.0010</p_value>
            <method>Stratified Wilcoxon Rank Sum Test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort A: Number of Weeks of RT-qPCR Confirmed SARS-CoV-2 Infection (Regardless of Symptoms) During the EAP</title>
        <time_frame>Up to 1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Placebo of R10933 + R10987</title>
            <description>Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
          <group group_id="O2">
            <title>Cohort A: R10933 + R10987</title>
            <description>Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort A: Number of Weeks of RT-qPCR Confirmed SARS-CoV-2 Infection (Regardless of Symptoms) During the EAP</title>
          <units>weeks</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="752"/>
                <count group_id="O2" value="753"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.31" spread="0.854" lower_limit="0.854"/>
                    <measurement group_id="O2" value="0.05" spread="0.260" lower_limit="0.260"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.0001</p_value>
            <method>Stratified Wilcoxon Rank Sum Test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort A: Percentage of Participants Who Have a RT-qPCR Confirmed SARS-CoV-2 Infection (Regardless of Symptoms) During the EAP</title>
        <description>The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:&gt;=12 to=50), and region (US vs ex-US)</description>
        <time_frame>Up to 1 month</time_frame>
        <population>Estimate of percentage of participants meeting the criteria based on fixed categories</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Placebo of R10933 + R10987</title>
            <description>Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
          <group group_id="O2">
            <title>Cohort A: R10933 + R10987</title>
            <description>Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort A: Percentage of Participants Who Have a RT-qPCR Confirmed SARS-CoV-2 Infection (Regardless of Symptoms) During the EAP</title>
          <description>The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:&gt;=12 to=50), and region (US vs ex-US)</description>
          <population>Estimate of percentage of participants meeting the criteria based on fixed categories</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="752"/>
                <count group_id="O2" value="753"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.56"/>
                    <measurement group_id="O2" value="5.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.0001</p_value>
            <method>Multiple Imputation, Logistic Regression</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.31</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.208</ci_lower_limit>
            <ci_upper_limit>0.456</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort A: Percentage of Participants in Placebo Group With a RT-qPCR Confirmed SARS-CoV-2 Infection During the EAP With an Index Case Participating in Study R10933-10987-COV-2067 (NCT04425629)</title>
        <time_frame>Up to 1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Placebo of R10933 + R10987</title>
            <description>Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort A: Percentage of Participants in Placebo Group With a RT-qPCR Confirmed SARS-CoV-2 Infection During the EAP With an Index Case Participating in Study R10933-10987-COV-2067 (NCT04425629)</title>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="186"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>% with index case receiving R10933+R10987 in 2067</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>% with index case receiving placebo in 2067</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>% with index case treatment in 2067 not available</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort A: Percentage of Participants With a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (CDC Definition) During the EAP</title>
        <description>Symptomatic SARS-CoV-2 infection (CDC definition) is defined as a positive central lab SARS-CoV-2 RT-qPCR result (either NP, nasal or saliva) associated with signs and symptoms with the onset date occurring within 14 days of a positive RT-qPCR during the EAP. Percentage estimated by Logistic Regression.</description>
        <time_frame>Up to 1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Placebo of R10933 + R10987</title>
            <description>Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
          <group group_id="O2">
            <title>Cohort A: R10933 + R10987</title>
            <description>Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort A: Percentage of Participants With a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (CDC Definition) During the EAP</title>
          <description>Symptomatic SARS-CoV-2 infection (CDC definition) is defined as a positive central lab SARS-CoV-2 RT-qPCR result (either NP, nasal or saliva) associated with signs and symptoms with the onset date occurring within 14 days of a positive RT-qPCR during the EAP. Percentage estimated by Logistic Regression.</description>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="752"/>
                <count group_id="O2" value="753"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.9"/>
                    <measurement group_id="O2" value="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.0001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.12</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.051</ci_lower_limit>
            <ci_upper_limit>0.286</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort A: Number of Weeks of Symptomatic RT-qPCR-confirmed SARS-CoV-2 Infection (CDC Definition) During the EAP</title>
        <time_frame>Up to 1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Placebo of R10933 + R10987</title>
            <description>Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
          <group group_id="O2">
            <title>Cohort A: R10933 + R10987</title>
            <description>Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort A: Number of Weeks of Symptomatic RT-qPCR-confirmed SARS-CoV-2 Infection (CDC Definition) During the EAP</title>
          <units>weeks</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="752"/>
                <count group_id="O2" value="753"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.21" spread="1.042" lower_limit="1.042"/>
                    <measurement group_id="O2" value="0.01" spread="0.128" lower_limit="0.128"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.0001</p_value>
            <method>Stratified Wilcoxon Rank Sum Test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Strict-term) During the EAP</title>
        <description>The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:&gt;=12 to=50), and region (US vs ex-US)</description>
        <time_frame>Up to 1 month</time_frame>
        <population>Estimate of percentage of participants meeting the criteria based on fixed categories</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Placebo of R10933 + R10987</title>
            <description>Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
          <group group_id="O2">
            <title>Cohort A: R10933 + R10987</title>
            <description>Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Strict-term) During the EAP</title>
          <description>The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:&gt;=12 to=50), and region (US vs ex-US)</description>
          <population>Estimate of percentage of participants meeting the criteria based on fixed categories</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="752"/>
                <count group_id="O2" value="753"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8"/>
                    <measurement group_id="O2" value="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>= 0.0010</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.09</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.020</ci_lower_limit>
            <ci_upper_limit>0.370</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort A: Number of Weeks of Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Strict-term) During the EAP</title>
        <time_frame>Up to 1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Placebo of R10933 + R10987</title>
            <description>Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
          <group group_id="O2">
            <title>Cohort A: R10933 + R10987</title>
            <description>Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort A: Number of Weeks of Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Strict-term) During the EAP</title>
          <units>weeks</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="752"/>
                <count group_id="O2" value="753"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.12" spread="0.843" lower_limit="0.843"/>
                    <measurement group_id="O2" value="0.00" spread="0.084" lower_limit="0.084"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.0001</p_value>
            <method>Stratified Wilcoxon Rank Sum Test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort A: Percentage of Participants Who Have a RT-qPCR Confirmed SARS-CoV-2 Infections at Each Week in the EAP</title>
        <time_frame>Week 1, Week 2, Week 3, Week 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Placebo of R10933 + R10987</title>
            <description>Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
          <group group_id="O2">
            <title>Cohort A: R10933 + R10987</title>
            <description>Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort A: Percentage of Participants Who Have a RT-qPCR Confirmed SARS-CoV-2 Infections at Each Week in the EAP</title>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="752"/>
                <count group_id="O2" value="753"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.9"/>
                    <measurement group_id="O2" value="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.5"/>
                    <measurement group_id="O2" value="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.7"/>
                    <measurement group_id="O2" value="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.6"/>
                    <measurement group_id="O2" value="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad-term) at Each Week in the EAP</title>
        <description>The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:&gt;=12 to=50), and region (US vs ex-US)</description>
        <time_frame>Week 1, Week 2, Week 3, Week 4</time_frame>
        <population>Estimate of percentage of participants meeting the criteria based on fixed categories</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Placebo of R10933 + R10987</title>
            <description>Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
          <group group_id="O2">
            <title>Cohort A: R10933 + R10987</title>
            <description>Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad-term) at Each Week in the EAP</title>
          <description>The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:&gt;=12 to=50), and region (US vs ex-US)</description>
          <population>Estimate of percentage of participants meeting the criteria based on fixed categories</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="752"/>
                <count group_id="O2" value="753"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.2"/>
                    <measurement group_id="O2" value="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8"/>
                    <measurement group_id="O2" value="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1"/>
                    <measurement group_id="O2" value="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort A: Time-weighted Average of Viral Load From the First Positive SARS CoV-2 RT-qPCR in NP Swab Samples (That Has an Onset During the EAP) Until the Third Weekly Visit After the First Positive Test During the EAP</title>
        <time_frame>Up to 1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Placebo of R10933 + R10987</title>
            <description>Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
          <group group_id="O2">
            <title>Cohort A: R10933 + R10987</title>
            <description>Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort A: Time-weighted Average of Viral Load From the First Positive SARS CoV-2 RT-qPCR in NP Swab Samples (That Has an Onset During the EAP) Until the Third Weekly Visit After the First Positive Test During the EAP</title>
          <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="107"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.065" spread="0.243" lower_limit="0.243"/>
                    <measurement group_id="O2" value="0.942" spread="0.317" lower_limit="0.317"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.0001</p_value>
            <method>ANOVA</method>
            <param_type>Difference of LS Means</param_type>
            <param_value>-2.123</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.295</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.707</ci_lower_limit>
            <ci_upper_limit>-1.539</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort A: Time-weighted Average of Viral Load From the First Positive SARS-CoV-2 RT-qPCR in NP Swab Samples (That Has an Onset During the EAP) Until the Second Weekly Visit After the First Positive Test During the EAP</title>
        <time_frame>Up to 1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Placebo of R10933 + R10987</title>
            <description>Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
          <group group_id="O2">
            <title>Cohort A: R10933 + R10987</title>
            <description>Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort A: Time-weighted Average of Viral Load From the First Positive SARS-CoV-2 RT-qPCR in NP Swab Samples (That Has an Onset During the EAP) Until the Second Weekly Visit After the First Positive Test During the EAP</title>
          <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="107"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.689" spread="0.281" lower_limit="0.281"/>
                    <measurement group_id="O2" value="1.205" spread="0.368" lower_limit="0.368"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.0001</p_value>
            <method>ANOVA</method>
            <param_type>Difference of LS Means</param_type>
            <param_value>-2.483</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.342</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.161</ci_lower_limit>
            <ci_upper_limit>-1.806</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort A: Maximum SARS-CoV-2 RT-qPCR Viral Load in NP Swab Samples Among Individuals With ≥1 RT-qPCR Positive That Has an Onset During the EAP</title>
        <time_frame>Up to 1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Placebo of R10933 + R10987</title>
            <description>Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
          <group group_id="O2">
            <title>Cohort A: R10933 + R10987</title>
            <description>Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort A: Maximum SARS-CoV-2 RT-qPCR Viral Load in NP Swab Samples Among Individuals With ≥1 RT-qPCR Positive That Has an Onset During the EAP</title>
          <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="107"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.133" spread="0.301" lower_limit="0.301"/>
                    <measurement group_id="O2" value="3.705" spread="0.402" lower_limit="0.402"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.0001</p_value>
            <method>ANOVA</method>
            <param_type>Difference of LS Mean</param_type>
            <param_value>-2.428</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.389</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.196</ci_lower_limit>
            <ci_upper_limit>-1.659</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort A: SARS-CoV-2 RT-qPCR Viral Load in NP Swab Samples Corresponding to the Onset of First Positive RT-qPCR During the EAP</title>
        <time_frame>Up to 1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Placebo of R10933 + R10987</title>
            <description>Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
          <group group_id="O2">
            <title>Cohort A: R10933 + R10987</title>
            <description>Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort A: SARS-CoV-2 RT-qPCR Viral Load in NP Swab Samples Corresponding to the Onset of First Positive RT-qPCR During the EAP</title>
          <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="107"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.141" spread="0.305" lower_limit="0.305"/>
                    <measurement group_id="O2" value="3.700" spread="0.396" lower_limit="0.396"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.0001</p_value>
            <method>ANOVA</method>
            <param_type>Difference of LS Mean</param_type>
            <param_value>-2.441</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.381</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.194</ci_lower_limit>
            <ci_upper_limit>-1.688</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort A: Area Under the Curve (AUC) in Viral Load From the First Positive SARS-CoV-2 RT-qPCR NP Swab Samples Detected During the EAP Until the First Confirmed Negative Test</title>
        <time_frame>Up to 1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Placebo of R10933 + R10987</title>
            <description>Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
          <group group_id="O2">
            <title>Cohort A: R10933 + R10987</title>
            <description>Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort A: Area Under the Curve (AUC) in Viral Load From the First Positive SARS-CoV-2 RT-qPCR NP Swab Samples Detected During the EAP Until the First Confirmed Negative Test</title>
          <units>log10 copies/milliLiter * days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.982" spread="47.6933" lower_limit="47.6933"/>
                    <measurement group_id="O2" value="19.700" spread="14.8257" lower_limit="14.8257"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort A: Total Number of Medically Attended Visits in Emergency Rooms or Urgent Care Centers Related to a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset During the EAP</title>
        <description>Medically attended visits referred to hospitalizations, Emergency Room visits, or visits at an Urgent Care center.</description>
        <time_frame>Up to 1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Placebo of R10933 + R10987</title>
            <description>Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
          <group group_id="O2">
            <title>Cohort A: R10933 + R10987</title>
            <description>Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort A: Total Number of Medically Attended Visits in Emergency Rooms or Urgent Care Centers Related to a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset During the EAP</title>
          <description>Medically attended visits referred to hospitalizations, Emergency Room visits, or visits at an Urgent Care center.</description>
          <units>medically attended visits</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="752"/>
                <count group_id="O2" value="753"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort A: Percentage of Participants With at Least 1 COVID-19-related Hospitalization or Emergency Room Visit Associated With a Positive RT-qPCR During the EAP or All-cause Death</title>
        <time_frame>Up to 1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Placebo of R10933 + R10987</title>
            <description>Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
          <group group_id="O2">
            <title>Cohort A: R10933 + R10987</title>
            <description>Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort A: Percentage of Participants With at Least 1 COVID-19-related Hospitalization or Emergency Room Visit Associated With a Positive RT-qPCR During the EAP or All-cause Death</title>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="752"/>
                <count group_id="O2" value="753"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Testing if there is an association between the observed results and treatment received</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>= 0.0621</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort A: Percentage of Participants Requiring Medically Attended Visits in Emergency Rooms or Urgent Care Centers Related to a RT-qPCR Confirmed SARS CoV-2 Infection That Has an Onset During the EAP</title>
        <time_frame>Up to 1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Placebo of R10933 + R10987</title>
            <description>Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
          <group group_id="O2">
            <title>Cohort A: R10933 + R10987</title>
            <description>Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort A: Percentage of Participants Requiring Medically Attended Visits in Emergency Rooms or Urgent Care Centers Related to a RT-qPCR Confirmed SARS CoV-2 Infection That Has an Onset During the EAP</title>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="752"/>
                <count group_id="O2" value="753"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Testing if there is an association between the observed results and treatment received'</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>= 0.0038</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort A: Proportion of Participants Hospitalized Related to a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset During the EAP</title>
        <description>The proportion of participants hospitalized related to a RT-qPCR confirmed SARS-CoV-2 infection that has an onset during the EAP</description>
        <time_frame>Up to 14 Days</time_frame>
        <population>Estimate of proportion of participants meeting the criteria based on fixed categories</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Placebo of R10933 + R10987</title>
            <description>Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
          <group group_id="O2">
            <title>Cohort A: R10933 + R10987</title>
            <description>Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort A: Proportion of Participants Hospitalized Related to a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset During the EAP</title>
          <description>The proportion of participants hospitalized related to a RT-qPCR confirmed SARS-CoV-2 infection that has an onset during the EAP</description>
          <population>Estimate of proportion of participants meeting the criteria based on fixed categories</population>
          <units>Proportion of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="752"/>
                <count group_id="O2" value="753"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.001"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort A: Number of Days of Hospital and Intensive Care Unit (ICU) Stay in Participants Hospitalized for a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset During the EAP</title>
        <time_frame>Up to Day 29</time_frame>
        <population>Only 1 participant in placebo group hospitalized</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Placebo of R10933 + R10987</title>
            <description>Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
          <group group_id="O2">
            <title>Cohort A: R10933 + R10987</title>
            <description>Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort A: Number of Days of Hospital and Intensive Care Unit (ICU) Stay in Participants Hospitalized for a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset During the EAP</title>
          <population>Only 1 participant in placebo group hospitalized</population>
          <units>Days</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort A: Number of Days Missed for Daily Responsibilities Due to a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset During the EAP</title>
        <description>Daily responsibilities including work (employed adults) or school (students), daycare or family obligations/responsibilities (childcare or eldercare)</description>
        <time_frame>Up to 1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Placebo of R10933 + R10987</title>
            <description>Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
          <group group_id="O2">
            <title>Cohort A: R10933 + R10987</title>
            <description>Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort A: Number of Days Missed for Daily Responsibilities Due to a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset During the EAP</title>
          <description>Daily responsibilities including work (employed adults) or school (students), daycare or family obligations/responsibilities (childcare or eldercare)</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="752"/>
                <count group_id="O2" value="753"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.98" spread="4.659" lower_limit="4.659"/>
                    <measurement group_id="O2" value="0.15" spread="1.276" lower_limit="1.276"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.0001</p_value>
            <method>Stratified Wilcoxon Rank Sum Test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort A: Proportion of Baseline Seropositive Participants (Based on Central Lab Test) With TEAEs and Severity of TEAEs</title>
        <time_frame>Up to 8 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Placebo of R10933 + R10987</title>
            <description>Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
          <group group_id="O2">
            <title>Cohort A: R10933 + R10987</title>
            <description>Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort A: Proportion of Baseline Seropositive Participants (Based on Central Lab Test) With TEAEs and Severity of TEAEs</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="296"/>
                <count group_id="O2" value="337"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>with at least one TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79"/>
                    <measurement group_id="O2" value="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>with at least one serious TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the EAP</title>
        <time_frame>Up to Day 29</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Placebo of R10933 + R10987</title>
            <description>Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
          <group group_id="O2">
            <title>Cohort A: R10933 + R10987</title>
            <description>Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
          <group group_id="O3">
            <title>Cohort B: Placebo of R10933 + R10987</title>
            <description>Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive</description>
          </group>
          <group group_id="O4">
            <title>Cohort B: R10933 + R10987</title>
            <description>Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the EAP</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1428"/>
                <count group_id="O2" value="1439"/>
                <count group_id="O3" value="170"/>
                <count group_id="O4" value="165"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total Symptomatic COVID-19</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="57"/>
                    <measurement group_id="O4" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 1 Symptomatic COVID-19</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="43"/>
                    <measurement group_id="O4" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 2 Symptomatic COVID-19</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="12"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Symptomatic COVID-19</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4 Symptomatic COVID-19</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 5 Symptomatic COVID-19</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the Follow-Up Period</title>
        <time_frame>Day 30 Up to Day 225 (Approximately 8 months)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Placebo of R10933 + R10987</title>
            <description>Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
          <group group_id="O2">
            <title>Cohort A: R10933 + R10987</title>
            <description>Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
          <group group_id="O3">
            <title>Cohort B: Placebo of R10933 + R10987</title>
            <description>Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive</description>
          </group>
          <group group_id="O4">
            <title>Cohort B: R10933 + R10987</title>
            <description>Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the Follow-Up Period</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1428"/>
                <count group_id="O2" value="1439"/>
                <count group_id="O3" value="170"/>
                <count group_id="O4" value="165"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total Symptomatic COVID-19</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68"/>
                    <measurement group_id="O2" value="14"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 1 Symptomatic COVID-19</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 2 Symptomatic COVID-19</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Symptomatic COVID-19</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4 Symptomatic COVID-19</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 5 Symptomatic COVID-19</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the EAP</title>
        <time_frame>Up to Day 29</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Placebo of R10933 + R10987</title>
            <description>Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
          <group group_id="O2">
            <title>Cohort A: R10933 + R10987</title>
            <description>Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
          <group group_id="O3">
            <title>Cohort B: Placebo of R10933 + R10987</title>
            <description>Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive</description>
          </group>
          <group group_id="O4">
            <title>Cohort B: R10933 + R10987</title>
            <description>Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the EAP</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1067"/>
                <count group_id="O2" value="1028"/>
                <count group_id="O3" value="114"/>
                <count group_id="O4" value="109"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total Symptomatic COVID-19</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="47"/>
                    <measurement group_id="O4" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 1 Symptomatic COVID-19</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="35"/>
                    <measurement group_id="O4" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 2 Symptomatic COVID-19</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Symptomatic COVID-19</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4 Symptomatic COVID-19</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 5 Symptomatic COVID-19</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the Follow-Up Period</title>
        <time_frame>Day 30 Up to Day 225 (Approximately 8 months)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Placebo of R10933 + R10987</title>
            <description>Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
          <group group_id="O2">
            <title>Cohort A: R10933 + R10987</title>
            <description>Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
          <group group_id="O3">
            <title>Cohort B: Placebo of R10933 + R10987</title>
            <description>Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive</description>
          </group>
          <group group_id="O4">
            <title>Cohort B: R10933 + R10987</title>
            <description>Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the Follow-Up Period</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1067"/>
                <count group_id="O2" value="1028"/>
                <count group_id="O3" value="114"/>
                <count group_id="O4" value="109"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total Symptomatic COVID-19</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 1 Symptomatic COVID-19</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 2 Symptomatic COVID-19</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Symptomatic COVID-19</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4 Symptomatic COVID-19</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 5 Symptomatic COVID-19</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the EAP</title>
        <time_frame>Up to Day 29</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Placebo of R10933 + R10987</title>
            <description>Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
          <group group_id="O2">
            <title>Cohort A: R10933 + R10987</title>
            <description>Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
          <group group_id="O3">
            <title>Cohort B: Placebo of R10933 + R10987</title>
            <description>Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive</description>
          </group>
          <group group_id="O4">
            <title>Cohort B: R10933 + R10987</title>
            <description>Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the EAP</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="296"/>
                <count group_id="O2" value="337"/>
                <count group_id="O3" value="43"/>
                <count group_id="O4" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total Symptomatic COVID-19</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 1 Symptomatic COVID-19</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 2 Symptomatic COVID-19</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Symptomatic COVID-19</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4 Symptomatic COVID-19</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 5 Symptomatic COVID-19</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the Follow-Up Period</title>
        <time_frame>Day 30 Up to Day 225 (Approximately 8 months)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Placebo of R10933 + R10987</title>
            <description>Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
          <group group_id="O2">
            <title>Cohort A: R10933 + R10987</title>
            <description>Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
          <group group_id="O3">
            <title>Cohort B: Placebo of R10933 + R10987</title>
            <description>Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive</description>
          </group>
          <group group_id="O4">
            <title>Cohort B: R10933 + R10987</title>
            <description>Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the Follow-Up Period</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="296"/>
                <count group_id="O2" value="337"/>
                <count group_id="O3" value="43"/>
                <count group_id="O4" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total Symptomatic COVID-19</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 1 Symptomatic COVID-19</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 2 Symptomatic COVID-19</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3Symptomatic COVID-19</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4 Symptomatic COVID-19</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 5 Symptomatic COVID-19</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort B: Number of Weeks of Symptomatic SARS-CoV-2 Infection (Broad-term) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP</title>
        <time_frame>Up to 14 Days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort B: Placebo of R10933 + R10987</title>
            <description>Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: R10933 + R10987</title>
            <description>Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort B: Number of Weeks of Symptomatic SARS-CoV-2 Infection (Broad-term) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP</title>
          <units>weeks</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="104"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.64" spread="3.493" lower_limit="3.493"/>
                    <measurement group_id="O2" value="0.90" spread="2.586" lower_limit="2.586"/>
                  </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>= 0.0273</p_value>
            <method>Stratified Wilcoxon Rank Sum Test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort B: Percentage of Participants With Asymptomatic Infection Who Develop Signs and Symptoms (CDC Definition) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP</title>
        <description>The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:&gt;=12 to=50), and region (US vs ex-US)</description>
        <time_frame>Up to 1 month</time_frame>
        <population>Estimate of percentage of participants meeting the criteria based on fixed categories</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort B: Placebo of R10933 + R10987</title>
            <description>Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: R10933 + R10987</title>
            <description>Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort B: Percentage of Participants With Asymptomatic Infection Who Develop Signs and Symptoms (CDC Definition) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP</title>
          <description>The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:&gt;=12 to=50), and region (US vs ex-US)</description>
          <population>Estimate of percentage of participants meeting the criteria based on fixed categories</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="104"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.7"/>
                    <measurement group_id="O2" value="26.3"/>
                  </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>= 0.0460</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.54</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.299</ci_lower_limit>
            <ci_upper_limit>0.989</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort B: Percentage of Participants Who Subsequently Develop Signs and Symptoms (Strict-term) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP</title>
        <description>The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:&gt;=12 to=50), and region (US vs ex-US)</description>
        <time_frame>Up to 14 Days</time_frame>
        <population>Estimate of percentage of participants meeting the criteria based on fixed categories</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort B: Placebo of R10933 + R10987</title>
            <description>Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: R10933 + R10987</title>
            <description>Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort B: Percentage of Participants Who Subsequently Develop Signs and Symptoms (Strict-term) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP</title>
          <description>The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:&gt;=12 to=50), and region (US vs ex-US)</description>
          <population>Estimate of percentage of participants meeting the criteria based on fixed categories</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="104"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.5"/>
                    <measurement group_id="O2" value="9.7"/>
                  </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>= 0.0721</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.47</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.207</ci_lower_limit>
            <ci_upper_limit>1.070</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort B: Number of Weeks of Symptomatic SARS-CoV-2 Infection (CDC Definition) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP</title>
        <time_frame>Up to 14 Days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort B: Placebo of R10933 + R10987</title>
            <description>Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: R10933 + R10987</title>
            <description>Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort B: Number of Weeks of Symptomatic SARS-CoV-2 Infection (CDC Definition) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP</title>
          <units>weeks</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="104"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.71" spread="3.569" lower_limit="3.569"/>
                    <measurement group_id="O2" value="0.88" spread="2.584" lower_limit="2.584"/>
                  </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>= 0.0260</p_value>
            <method>Stratified Wilcoxon Rank Sum Test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort B: Number of Weeks of Symptomatic SARS-CoV-2 Infection (Strict-term Definition) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP</title>
        <time_frame>Up to 14 Days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort B: Placebo of R10933 + R10987</title>
            <description>Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: R10933 + R10987</title>
            <description>Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort B: Number of Weeks of Symptomatic SARS-CoV-2 Infection (Strict-term Definition) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP</title>
          <units>weeks</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="104"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.68" spread="1.889" lower_limit="1.889"/>
                    <measurement group_id="O2" value="0.40" spread="1.876" lower_limit="1.876"/>
                  </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>= 0.0614</p_value>
            <method>Stratified Wilcoxon Rank Sum Test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort B: Change in Viral Load From Baseline to Day 8 Visit in NP Swab Samples</title>
        <time_frame>Up to day 8 visit</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort B: Placebo of R10933 + R10987</title>
            <description>Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: R10933 + R10987</title>
            <description>Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort B: Change in Viral Load From Baseline to Day 8 Visit in NP Swab Samples</title>
          <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="97"/>
                <count group_id="O2" value="95"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.543" spread="0.238" lower_limit="0.238"/>
                    <measurement group_id="O2" value="-3.004" spread="0.239" lower_limit="0.239"/>
                  </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>&lt; 0.0001</p_value>
            <method>ANCOVA</method>
            <param_type>LS mean difference</param_type>
            <param_value>-1.461</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.337</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.127</ci_lower_limit>
            <ci_upper_limit>-0.795</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort B: Change in Viral Load From Baseline to Day 15 Visit in NP Swab Samples</title>
        <time_frame>Up to day 15 visit</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort B: Placebo of R10933 + R10987</title>
            <description>Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: R10933 + R10987</title>
            <description>Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort B: Change in Viral Load From Baseline to Day 15 Visit in NP Swab Samples</title>
          <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="97"/>
                <count group_id="O2" value="95"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.014" spread="0.195" lower_limit="0.195"/>
                    <measurement group_id="O2" value="-4.864" spread="0.199" lower_limit="0.199"/>
                  </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>= 0.0026</p_value>
            <method>ANCOVA</method>
            <param_type>LS mean difference</param_type>
            <param_value>-0.850</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.279</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.400</ci_lower_limit>
            <ci_upper_limit>-0.300</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort B: Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL) in NP Swab Samples Until the Day 22 Visit</title>
        <time_frame>Day 22</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort B: Placebo of R10933 + R10987</title>
            <description>Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: R10933 + R10987</title>
            <description>Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort B: Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL) in NP Swab Samples Until the Day 22 Visit</title>
          <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="96"/>
                <count group_id="O2" value="95"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.639" spread="0.136" lower_limit="0.136"/>
                    <measurement group_id="O2" value="-3.580" spread="0.137" lower_limit="0.137"/>
                  </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>&lt; 0.0001</p_value>
            <method>ANCOVA</method>
            <param_type>LS mean difference</param_type>
            <param_value>-0.940</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.193</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.321</ci_lower_limit>
            <ci_upper_limit>-0.559</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort B: AUC in Viral Load From the First Positive SARS-CoV-2 RT-qPCR NP Swab Samples Detected During the EAP to the First Confirmed Negative Test</title>
        <time_frame>Up to 14 Days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort B: Placebo of R10933 + R10987</title>
            <description>Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: R10933 + R10987</title>
            <description>Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort B: AUC in Viral Load From the First Positive SARS-CoV-2 RT-qPCR NP Swab Samples Detected During the EAP to the First Confirmed Negative Test</title>
          <units>log10 copies/milliLiter*days</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="101"/>
                <count group_id="O2" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.008" spread="4.328" lower_limit="4.328"/>
                    <measurement group_id="O2" value="55.964" spread="4.201" lower_limit="4.201"/>
                  </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>&lt; 0.0001</p_value>
            <method>ANCOVA</method>
            <param_type>Difference of LS Mean</param_type>
            <param_value>-26.045</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>6.041</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-37.973</ci_lower_limit>
            <ci_upper_limit>-14.117</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort B: Maximum SARS-CoV-2 RT-qPCR Viral Load in NP Swab Samples in Participants With 1 or More Positive Test That Has an Onset During the EAP</title>
        <time_frame>Up to 1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort B: Placebo of R10933 + R10987</title>
            <description>Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: R10933 + R10987</title>
            <description>Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort B: Maximum SARS-CoV-2 RT-qPCR Viral Load in NP Swab Samples in Participants With 1 or More Positive Test That Has an Onset During the EAP</title>
          <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="101"/>
                <count group_id="O2" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.731" spread="0.238" lower_limit="0.238"/>
                    <measurement group_id="O2" value="3.336" spread="0.240" lower_limit="0.240"/>
                  </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>&lt; 0.0001</p_value>
            <method>ANCOVA</method>
            <param_type>Difference of LS Mean</param_type>
            <param_value>-1.395</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.338</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.063</ci_lower_limit>
            <ci_upper_limit>-0.727</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort B: Number of Medically Attended Visits in Emergency Rooms or Urgent Care Centers Related to RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset at Baseline or During the EAP</title>
        <time_frame>Up to 1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort B: Placebo of R10933 + R10987</title>
            <description>Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: R10933 + R10987</title>
            <description>Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort B: Number of Medically Attended Visits in Emergency Rooms or Urgent Care Centers Related to RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset at Baseline or During the EAP</title>
          <units>Medically attended visits</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="104"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.06" spread="0.234" lower_limit="0.234"/>
                    <measurement group_id="O2" value="0.00" spread="0.000" lower_limit="0.000"/>
                  </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>= 0.0138</p_value>
            <method>Stratified Wilcoxon Rank Sum Test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort B: Percentage of Participants Requiring Medically Attended Visits in Emergency Rooms or Urgent Care Centers Related to a RT-qPCR Confirmed SARS CoV-2 Infection That Has an Onset at Baseline or During the EAP</title>
        <time_frame>Up to 1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort B: Placebo of R10933 + R10987</title>
            <description>Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: R10933 + R10987</title>
            <description>Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort B: Percentage of Participants Requiring Medically Attended Visits in Emergency Rooms or Urgent Care Centers Related to a RT-qPCR Confirmed SARS CoV-2 Infection That Has an Onset at Baseline or During the EAP</title>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="104"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.8"/>
                    <measurement group_id="O2" value="0.0"/>
                  </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>
            <groups_desc>Testing if there is an association between the observed results and treatment received</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>= 0.0292</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort B: Percentage of Participants Hospitalized Related to a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset at Baseline or During the EAP</title>
        <time_frame>Up to 14 Days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort B: Placebo of R10933 + R10987</title>
            <description>Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: R10933 + R10987</title>
            <description>Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort B: Percentage of Participants Hospitalized Related to a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset at Baseline or During the EAP</title>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="104"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9"/>
                    <measurement group_id="O2" value="0.0"/>
                  </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>
            <groups_desc>Testing if there is an association between the observed results and treatment received</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>= 0.2466</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort B: Number of Days Missed for Daily Responsibilities (Where Applicable) Due to a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset at Baseline or During the EAP</title>
        <time_frame>Up to 1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort B: Placebo of R10933 + R10987</title>
            <description>Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: R10933 + R10987</title>
            <description>Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort B: Number of Days Missed for Daily Responsibilities (Where Applicable) Due to a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset at Baseline or During the EAP</title>
          <units>Days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="104"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.69" spread="8.802" lower_limit="8.802"/>
                    <measurement group_id="O2" value="5.18" spread="8.940" lower_limit="8.940"/>
                  </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>= 0.7861</p_value>
            <method>Stratified Wilcoxon Rank Sum test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort B: Number of Days of Hospital and Intensive Care Unit (ICU) Stay in Participants Hospitalized for a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset at Baseline or During the EAP</title>
        <time_frame>Up to 1 month</time_frame>
        <population>Estimate of proportion of participants meeting the criteria</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort B: Placebo of R10933 + R10987</title>
            <description>Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: R10933 + R10987</title>
            <description>Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort B: Number of Days of Hospital and Intensive Care Unit (ICU) Stay in Participants Hospitalized for a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset at Baseline or During the EAP</title>
          <population>Estimate of proportion of participants meeting the criteria</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="104"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.38" spread="2.671" lower_limit="2.671"/>
                    <measurement group_id="O2" value="0.00" spread="0.000" lower_limit="0.000"/>
                  </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>= 0.0842</p_value>
            <method>Stratified Wilcoxon Rank Sum test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Concentrations of REGN10987 in Serum Over Time (Cohort A)</title>
        <time_frame>0 Days Post-Dose, 28 Days Post-Dose, 56 Days Post-Dose, 112 Days Post-Dose</time_frame>
        <population>Number of participants in Cohort A with reportable concentrations obtained from baseline to day 112 of study for REGN10987 only. This PK analysis set (PKAS: Safety Subset) includes all treated subjects who received any study drug and had at least 1 non-missing imdevimab measurement following study drug administration. The PK analysis safety subset is based on the actual treatment received (as treated) rather than as randomized</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: R10933 + R10987</title>
            <description>Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
        </group_list>
        <measure>
          <title>Concentrations of REGN10987 in Serum Over Time (Cohort A)</title>
          <population>Number of participants in Cohort A with reportable concentrations obtained from baseline to day 112 of study for REGN10987 only. This PK analysis set (PKAS: Safety Subset) includes all treated subjects who received any study drug and had at least 1 non-missing imdevimab measurement following study drug administration. The PK analysis safety subset is based on the actual treatment received (as treated) rather than as randomized</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="138"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>0 Days Post-Dose (n=107)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0233" spread="0.145"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>28 Days Post-Dose (n=74)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.6" spread="9.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>56 Days Post-Dose (n=105)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.4" spread="5.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>112 Days Post-Dose (n=88)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.10" spread="1.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Concentrations of REGN10987 in Serum Over Time (Cohort B)</title>
        <time_frame>0 Days Post-Dose, 28 Days Post-Dose, 56 Days Post-Dose, 112 Days Post-Dose</time_frame>
        <population>Number of participants in Cohort B with reportable concentrations obtained from baseline to day 112 of study for REGN10987 only. This PK analysis set (PKAS: Safety Subset) includes all treated subjects who received any study drug and had at least 1 non-missing imdevimab measurement following study drug administration. The PK analysis safety subset is based on the actual treatment received (as treated) rather than as randomized</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort B: R10933 + R10987</title>
            <description>Cohort B: R10933 + R10987 Adult and Adolescent Participants (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
        </group_list>
        <measure>
          <title>Concentrations of REGN10987 in Serum Over Time (Cohort B)</title>
          <population>Number of participants in Cohort B with reportable concentrations obtained from baseline to day 112 of study for REGN10987 only. This PK analysis set (PKAS: Safety Subset) includes all treated subjects who received any study drug and had at least 1 non-missing imdevimab measurement following study drug administration. The PK analysis safety subset is based on the actual treatment received (as treated) rather than as randomized</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="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>0 Days Post-Dose (n=7)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>28 Days Post-Dose (n=6)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.0" spread="8.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>56 Days Post-Dose (n=8)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.0" spread="6.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>112 Days Post-Dose (n=5)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.62" spread="3.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Concentrations of REGN10933 in Serum Over Time (Cohort A)</title>
        <time_frame>0 Days Post-Dose, 28 Days Post-Dose, 56 Days Post-Dose, 112 Days Post-Dose</time_frame>
        <population>Number of participants in Cohort A with reportable concentrations obtained from baseline to day 112 of study for REGN10933 only. This PK analysis set (PKAS: Safety Subset) includes all treated subjects who received any study drug and had at least 1 non-missing imdevimab measurement following study drug administration. The PK analysis safety subset is based on the actual treatment received (as treated) rather than as randomized</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: R10933 + R10987</title>
            <description>Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
        </group_list>
        <measure>
          <title>Concentrations of REGN10933 in Serum Over Time (Cohort A)</title>
          <population>Number of participants in Cohort A with reportable concentrations obtained from baseline to day 112 of study for REGN10933 only. This PK analysis set (PKAS: Safety Subset) includes all treated subjects who received any study drug and had at least 1 non-missing imdevimab measurement following study drug administration. The PK analysis safety subset is based on the actual treatment received (as treated) rather than as randomized</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="138"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>0 Days Post-Dose (n=107)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0190" spread="0.123"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>28 Days Post-Dose (n=73)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.8" spread="12.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>56 Days Post-Dose (n=106)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.8" spread="7.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>112 Days Post-Dose (n=88)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.61" spread="2.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Concentrations of REGN10933 in Serum Over Time (Cohort B)</title>
        <time_frame>0 Days Post-Dose, 28 Days Post-Dose, 56 Days Post-Dose, 112 Days Post-Dose</time_frame>
        <population>Number of participants in Cohort B with reportable concentrations obtained from baseline to day 112 of study for REGN10933 only. This PK analysis set (PKAS: Safety Subset) includes all treated subjects who received any study drug and had at least 1 non-missing imdevimab measurement following study drug administration. The PK analysis safety subset is based on the actual treatment received (as treated) rather than as randomized</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort B: R10933 + R10987</title>
            <description>Cohort B: R10933 + R10987 Adult and Adolescent Participants (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
        </group_list>
        <measure>
          <title>Concentrations of REGN10933 in Serum Over Time (Cohort B)</title>
          <population>Number of participants in Cohort B with reportable concentrations obtained from baseline to day 112 of study for REGN10933 only. This PK analysis set (PKAS: Safety Subset) includes all treated subjects who received any study drug and had at least 1 non-missing imdevimab measurement following study drug administration. The PK analysis safety subset is based on the actual treatment received (as treated) rather than as randomized</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="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>0 Days Post-Dose (n=7)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>28 Days Post-Dose (n=6)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.6" spread="13.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>56 Days Post-Dose (n=8)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.1" spread="9.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>112 Days Post-Dose (n=3)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.58" spread="3.02"/>
                  </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>Up to 8 months</time_frame>
        <population>This ADA analysis set (AAS) includes all treated subjects who received study drug and had at least 1 non-missing ADA result after study drug administration. The AAS is based on the actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Overall Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
          <group group_id="O2">
            <title>R10933 + R10987</title>
            <description>Participants received a single 1200mg intravenous dose of REGN10933+REGN10987</description>
          </group>
        </group_list>
        <measure>
          <title>Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933</title>
          <population>This ADA analysis set (AAS) includes all treated subjects who received study drug and had at least 1 non-missing ADA result after study drug administration. The AAS is based on the actual treatment received.</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="1606"/>
                <count group_id="O2" value="1595"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1544"/>
                    <measurement group_id="O2" value="1319"/>
                  </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>Up to 8 months</time_frame>
        <population>This ADA analysis set (AAS) includes all treated subjects who received study drug and had at least 1 non-missing ADA result after study drug administration. The AAS is based on the actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Overall Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
          <group group_id="O2">
            <title>R10987 +R10933</title>
            <description>Participants received a single 1200mg intravenous dose of REGN10933+REGN10987</description>
          </group>
        </group_list>
        <measure>
          <title>Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987</title>
          <population>This ADA analysis set (AAS) includes all treated subjects who received study drug and had at least 1 non-missing ADA result after study drug administration. The AAS is based on the actual treatment received.</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="1606"/>
                <count group_id="O2" value="1595"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1500"/>
                    <measurement group_id="O2" value="1251"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10933</title>
        <description>(TE&amp;TB+;NAb+) = TE = Treatment-Emergent; TB = Treatment-boosted; NAb+ = Positive in NAb assay</description>
        <time_frame>Up to 8 months</time_frame>
        <population>This ADA analysis set (AAS) includes all treated participants who received study drug and had at least 1 non-missing ADA result after study drug administration. The AAS is based on the actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Overall Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
          <group group_id="O2">
            <title>R10933 + R10987</title>
            <description>Participants received a single 1200mg intravenous dose of REGN10933+REGN10987</description>
          </group>
        </group_list>
        <measure>
          <title>Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10933</title>
          <description>(TE&amp;TB+;NAb+) = TE = Treatment-Emergent; TB = Treatment-boosted; NAb+ = Positive in NAb assay</description>
          <population>This ADA analysis set (AAS) includes all treated participants who received study drug and had at least 1 non-missing ADA result after study drug administration. The AAS is based on the actual treatment received.</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="1606"/>
                <count group_id="O2" value="1595"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987</title>
        <description>(TE&amp;TB+;NAb+) = TE = Treatment-emergent; TB = Treatment-boosted; NAb+ = Positive in NAb assay</description>
        <time_frame>Up to 8 Months</time_frame>
        <population>This ADA analysis set (AAS) includes all treated subjects who received study drug and had at least 1 non-missing ADA result after study drug administration. The AAS is based on the actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Overall Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
          </group>
          <group group_id="O2">
            <title>R10987 + R10987</title>
            <description>Participants received a single 1200mg intravenous dose of REGN10933+REGN10987</description>
          </group>
        </group_list>
        <measure>
          <title>Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987</title>
          <description>(TE&amp;TB+;NAb+) = TE = Treatment-emergent; TB = Treatment-boosted; NAb+ = Positive in NAb assay</description>
          <population>This ADA analysis set (AAS) includes all treated subjects who received study drug and had at least 1 non-missing ADA result after study drug administration. The AAS is based on the actual treatment received.</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="1606"/>
                <count group_id="O2" value="1595"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="160"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to day 226</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Cohort A Placebo</title>
          <description>Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
        </group>
        <group group_id="E2">
          <title>Cohort A R10933+R10987</title>
          <description>Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline</description>
        </group>
        <group group_id="E3">
          <title>Cohort A1 Placebo</title>
          <description>Cohort A1: Placebo of R10933 + R10987 Pediatric Subjects (&lt;12 years) with SARS-CoV-2 RT-qPCR Negative</description>
        </group>
        <group group_id="E4">
          <title>Cohort B Placebo</title>
          <description>Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive</description>
        </group>
        <group group_id="E5">
          <title>Cohort B R10933+R10987</title>
          <description>Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive</description>
        </group>
        <group group_id="E6">
          <title>Undetermined Placebo</title>
          <description>Undetermined: Placebo of R10933 + R10987 Adult and Adolescent subjects (≥12 years) whose baseline RT-qPCR status was inconclusive or missing</description>
        </group>
        <group group_id="E7">
          <title>Undetermined R10933+R10987</title>
          <description>Undetermined: R10933 + R10987 Adult and Adolescent subjects (≥12 years) whose baseline RT-qPCR status was inconclusive or missing</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="1428"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="1439"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="1428"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="1439"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="170"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="165"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1428"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1439"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1428"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1439"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1428"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1439"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Cardio-respiratory arrest</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1428"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1439"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1428"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1439"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1428"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1439"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1428"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1439"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1428"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1439"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="1428"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1439"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="170"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>COVID-19 pneumonia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="1428"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1439"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="170"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1428"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1439"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1428"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1439"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1428"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1439"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Scrotal abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1428"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1439"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1428"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1439"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Abscess limb</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1428"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1439"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Gangrene</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1428"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="1439"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1428"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1439"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1428"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1439"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Soft tissue infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1428"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1439"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Gun shot wound</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1428"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1439"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1428"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1439"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Soft tissue injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1428"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1439"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Ankle fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1428"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1439"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Burns second degree</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1428"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="1439"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Foot fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1428"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1439"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Post procedural complication</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1428"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1439"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Post procedural haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1428"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1439"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Post procedural inflammation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1428"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1439"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1428"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1439"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="165"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Tibia fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1428"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1439"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Traumatic lung injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1428"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1439"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Invasive ductal breast carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1428"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1439"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Cervix carcinoma recurrent</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1428"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1439"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1428"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1439"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1428"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1439"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1428"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1439"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Abortion spontaneous</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1428"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1439"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Pre-eclampsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1428"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1439"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1428"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1439"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Mania</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1428"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1439"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Schizophrenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1428"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1439"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </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="0" subjects_affected="0" subjects_at_risk="1428"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1439"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Breast haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1428"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1439"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic foot</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1428"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1439"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Essential hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1428"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1439"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Hypertensive urgency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1428"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1439"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </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="247" subjects_at_risk="1428"/>
                <counts group_id="E2" subjects_affected="96" subjects_at_risk="1439"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="63" subjects_at_risk="170"/>
                <counts group_id="E5" subjects_affected="41" subjects_at_risk="165"/>
                <counts group_id="E6" subjects_affected="10" subjects_at_risk="44"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" events="149" subjects_affected="148" subjects_at_risk="1428"/>
                <counts group_id="E2" events="32" subjects_affected="29" subjects_at_risk="1439"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="59" subjects_affected="58" subjects_at_risk="170"/>
                <counts group_id="E5" events="35" subjects_affected="35" subjects_at_risk="165"/>
                <counts group_id="E6" events="4" subjects_affected="4" subjects_at_risk="44"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Asymptomatic COVID-19</sub_title>
                <counts group_id="E1" events="119" subjects_affected="119" subjects_at_risk="1428"/>
                <counts group_id="E2" events="73" subjects_affected="71" subjects_at_risk="1439"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="6" subjects_affected="6" subjects_at_risk="170"/>
                <counts group_id="E5" events="7" subjects_affected="7" subjects_at_risk="165"/>
                <counts group_id="E6" events="7" subjects_affected="7" subjects_at_risk="44"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </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 Trials Administrator</name_or_title>
      <organization>Regeneron Pharmaceuticals, Inc.</organization>
      <phone>8447346643</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/NCT04452318
org study id: R10933-10987-COV-2069
secondary id: 2020-003654-71
nct id: NCT04452318
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Primary Objectives:

      Cohort A:

      • To evaluate the efficacy of REGN10933+REGN10987 compared to placebo in preventing
      symptomatic SARS-CoV-2 infection (broad-term) confirmed by RT-qPCR

      Cohort A and Cohort A1:

      • To evaluate the safety and tolerability of REGN10933+REGN10987 following subcutaneous (SC)
      administration compared to placebo

      Cohort B • To evaluate the efficacy of REGN10933+REGN10987 compared to placebo in preventing
      COVID-19 symptoms (broad-term)

      Cohort B and Cohort B1

      • To evaluate the safety and tolerability of REGN10933+REGN10987 following SC administration
      compared to placebo
Cohort A: adult and adolescent subjects (≥12 years) who are SARS -CoV-2 RT-qPCR negative at
      baseline

      Cohort A1: pediatric subjects (<12 years) who are SARS-CoV-2 RT--qPCR negative at baseline

      Cohort B: adult and adolescent subjects (≥12 years) who are SARS -CoV-2 RT-qPCR positive at
      baseline

      Cohort B1: pediatric subjects (<12 years) who are SARS-CoV-2 RT--qPCR positive at baseline
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad-term) During the EAP
time frame: Up to 1 month
description: Symptomatic SARS-CoV-2 infection (broad-term) is defined as a positive central lab SARS-CoV-2 RT-qPCR result (either NP, nasal or saliva) associated with signs and symptoms with the onset date occurring within 14 days of a positive RT-qPCR during the EAP. Percentage estimated by Logistic Regression.
measure: Cohort B: Percentage of Participants Who Subsequently Develop Signs and Symptoms (Broad-Term) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP
time frame: Up to 14 Days
description: The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:>=12 to=50), and region (US vs ex-US).
measure: Cohort A and Cohort B: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAEs) and Severity of TEAEs
time frame: Up to 8 months
measure: Cohort A and Cohort B: Percentage of Participants With High Viral Load in Nasopharyngeal (NP) Swab Samples During the EAP
time frame: Up to 1 month
description: High viral load (> 4 log 10 copies/ml)
measure: Cohort A: Number of Weeks of Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad Term) During the EAP
time frame: Up to 1 month
measure: Cohort A and Cohort B: Number of Weeks of High Viral Load in NP Swab Samples During the EAP
time frame: Up to 1 month
description: High viral load (> 4 log 10 copies/ml)
measure: Cohort A: Number of Weeks of RT-qPCR Confirmed SARS-CoV-2 Infection (Regardless of Symptoms) During the EAP
time frame: Up to 1 month
measure: Cohort A: Percentage of Participants Who Have a RT-qPCR Confirmed SARS-CoV-2 Infection (Regardless of Symptoms) During the EAP
time frame: Up to 1 month
description: The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:>=12 to=50), and region (US vs ex-US)
measure: Cohort A: Percentage of Participants in Placebo Group With a RT-qPCR Confirmed SARS-CoV-2 Infection During the EAP With an Index Case Participating in Study R10933-10987-COV-2067 (NCT04425629)
time frame: Up to 1 month
measure: Cohort A: Percentage of Participants With a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (CDC Definition) During the EAP
time frame: Up to 1 month
description: Symptomatic SARS-CoV-2 infection (CDC definition) is defined as a positive central lab SARS-CoV-2 RT-qPCR result (either NP, nasal or saliva) associated with signs and symptoms with the onset date occurring within 14 days of a positive RT-qPCR during the EAP. Percentage estimated by Logistic Regression.
measure: Cohort A: Number of Weeks of Symptomatic RT-qPCR-confirmed SARS-CoV-2 Infection (CDC Definition) During the EAP
time frame: Up to 1 month
measure: Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Strict-term) During the EAP
time frame: Up to 1 month
description: The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:>=12 to=50), and region (US vs ex-US)
measure: Cohort A: Number of Weeks of Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Strict-term) During the EAP
time frame: Up to 1 month
measure: Cohort A: Percentage of Participants Who Have a RT-qPCR Confirmed SARS-CoV-2 Infections at Each Week in the EAP
time frame: Week 1, Week 2, Week 3, Week 4
measure: Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad-term) at Each Week in the EAP
time frame: Week 1, Week 2, Week 3, Week 4
description: The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:>=12 to=50), and region (US vs ex-US)
measure: Cohort A: Time-weighted Average of Viral Load From the First Positive SARS CoV-2 RT-qPCR in NP Swab Samples (That Has an Onset During the EAP) Until the Third Weekly Visit After the First Positive Test During the EAP
time frame: Up to 1 month
measure: Cohort A: Time-weighted Average of Viral Load From the First Positive SARS-CoV-2 RT-qPCR in NP Swab Samples (That Has an Onset During the EAP) Until the Second Weekly Visit After the First Positive Test During the EAP
time frame: Up to 1 month
measure: Cohort A: Maximum SARS-CoV-2 RT-qPCR Viral Load in NP Swab Samples Among Individuals With ≥1 RT-qPCR Positive That Has an Onset During the EAP
time frame: Up to 1 month
measure: Cohort A: SARS-CoV-2 RT-qPCR Viral Load in NP Swab Samples Corresponding to the Onset of First Positive RT-qPCR During the EAP
time frame: Up to 1 month
measure: Cohort A: Area Under the Curve (AUC) in Viral Load From the First Positive SARS-CoV-2 RT-qPCR NP Swab Samples Detected During the EAP Until the First Confirmed Negative Test
time frame: Up to 1 month
measure: Cohort A: Total Number of Medically Attended Visits in Emergency Rooms or Urgent Care Centers Related to a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset During the EAP
time frame: Up to 1 month
description: Medically attended visits referred to hospitalizations, Emergency Room visits, or visits at an Urgent Care center.
measure: Cohort A: Percentage of Participants With at Least 1 COVID-19-related Hospitalization or Emergency Room Visit Associated With a Positive RT-qPCR During the EAP or All-cause Death
time frame: Up to 1 month
measure: Cohort A: Percentage of Participants Requiring Medically Attended Visits in Emergency Rooms or Urgent Care Centers Related to a RT-qPCR Confirmed SARS CoV-2 Infection That Has an Onset During the EAP
time frame: Up to 1 month
measure: Cohort A: Proportion of Participants Hospitalized Related to a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset During the EAP
time frame: Up to 14 Days
description: The proportion of participants hospitalized related to a RT-qPCR confirmed SARS-CoV-2 infection that has an onset during the EAP
measure: Cohort A: Number of Days of Hospital and Intensive Care Unit (ICU) Stay in Participants Hospitalized for a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset During the EAP
time frame: Up to Day 29
measure: Cohort A: Number of Days Missed for Daily Responsibilities Due to a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset During the EAP
time frame: Up to 1 month
description: Daily responsibilities including work (employed adults) or school (students), daycare or family obligations/responsibilities (childcare or eldercare)
measure: Cohort A: Proportion of Baseline Seropositive Participants (Based on Central Lab Test) With TEAEs and Severity of TEAEs
time frame: Up to 8 months
measure: Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the EAP
time frame: Up to Day 29
measure: Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the Follow-Up Period
time frame: Day 30 Up to Day 225 (Approximately 8 months)
measure: Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the EAP
time frame: Up to Day 29
measure: Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the Follow-Up Period
time frame: Day 30 Up to Day 225 (Approximately 8 months)
measure: Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the EAP
time frame: Up to Day 29
measure: Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the Follow-Up Period
time frame: Day 30 Up to Day 225 (Approximately 8 months)
measure: Cohort B: Number of Weeks of Symptomatic SARS-CoV-2 Infection (Broad-term) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP
time frame: Up to 14 Days
measure: Cohort B: Percentage of Participants With Asymptomatic Infection Who Develop Signs and Symptoms (CDC Definition) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP
time frame: Up to 1 month
description: The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:>=12 to=50), and region (US vs ex-US)
measure: Cohort B: Percentage of Participants Who Subsequently Develop Signs and Symptoms (Strict-term) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP
time frame: Up to 14 Days
description: The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:>=12 to=50), and region (US vs ex-US)
measure: Cohort B: Number of Weeks of Symptomatic SARS-CoV-2 Infection (CDC Definition) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP
time frame: Up to 14 Days
measure: Cohort B: Number of Weeks of Symptomatic SARS-CoV-2 Infection (Strict-term Definition) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP
time frame: Up to 14 Days
measure: Cohort B: Change in Viral Load From Baseline to Day 8 Visit in NP Swab Samples
time frame: Up to day 8 visit
measure: Cohort B: Change in Viral Load From Baseline to Day 15 Visit in NP Swab Samples
time frame: Up to day 15 visit
measure: Cohort B: Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL) in NP Swab Samples Until the Day 22 Visit
time frame: Day 22
measure: Cohort B: AUC in Viral Load From the First Positive SARS-CoV-2 RT-qPCR NP Swab Samples Detected During the EAP to the First Confirmed Negative Test
time frame: Up to 14 Days
measure: Cohort B: Maximum SARS-CoV-2 RT-qPCR Viral Load in NP Swab Samples in Participants With 1 or More Positive Test That Has an Onset During the EAP
time frame: Up to 1 month
measure: Cohort B: Number of Medically Attended Visits in Emergency Rooms or Urgent Care Centers Related to RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset at Baseline or During the EAP
time frame: Up to 1 month
measure: Cohort B: Percentage of Participants Requiring Medically Attended Visits in Emergency Rooms or Urgent Care Centers Related to a RT-qPCR Confirmed SARS CoV-2 Infection That Has an Onset at Baseline or During the EAP
time frame: Up to 1 month
measure: Cohort B: Percentage of Participants Hospitalized Related to a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset at Baseline or During the EAP
time frame: Up to 14 Days
measure: Cohort B: Number of Days Missed for Daily Responsibilities (Where Applicable) Due to a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset at Baseline or During the EAP
time frame: Up to 1 month
measure: Cohort B: Number of Days of Hospital and Intensive Care Unit (ICU) Stay in Participants Hospitalized for a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset at Baseline or During the EAP
time frame: Up to 1 month
measure: Concentrations of REGN10987 in Serum Over Time (Cohort A)
time frame: 0 Days Post-Dose, 28 Days Post-Dose, 56 Days Post-Dose, 112 Days Post-Dose
measure: Concentrations of REGN10987 in Serum Over Time (Cohort B)
time frame: 0 Days Post-Dose, 28 Days Post-Dose, 56 Days Post-Dose, 112 Days Post-Dose
measure: Concentrations of REGN10933 in Serum Over Time (Cohort A)
time frame: 0 Days Post-Dose, 28 Days Post-Dose, 56 Days Post-Dose, 112 Days Post-Dose
measure: Concentrations of REGN10933 in Serum Over Time (Cohort B)
time frame: 0 Days Post-Dose, 28 Days Post-Dose, 56 Days Post-Dose, 112 Days Post-Dose
measure: Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933
time frame: Up to 8 months
measure: Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987
time frame: Up to 8 months
measure: Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10933
time frame: Up to 8 months
description: (TE&TB+;NAb+) = TE = Treatment-Emergent; TB = Treatment-boosted; NAb+ = Positive in NAb assay
measure: Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987
time frame: Up to 8 Months
description: (TE&TB+;NAb+) = TE = Treatment-emergent; TB = Treatment-boosted; NAb+ = Positive in NAb assay
arm group label: REGN10933 + REGN10987
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: REGN10933 + REGN10987
description: Subcutaneous (SC) or Intramuscular (IM) injections
arm group label: REGN10933 + REGN10987
other name: REGN-COV2
other name: Casirivimab
other name: Imdevimab
other name: REGEN-COV™
intervention type: Drug
intervention name: Placebo
description: SC or IM injections
arm group label: Placebo
criteria: 
gender: All
minimum age: 1 Day
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Clinical Trial Management
role: Study Director
affiliation: Regeneron Pharmaceuticals
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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., 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/
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point of contact: 