<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/NCT04427501</url>
  </required_header>
  <id_info>
    <org_study_id>17947</org_study_id>
    <secondary_id>J2W-MC-PYAB</secondary_id>
    <nct_id>NCT04427501</nct_id>
  </id_info>
  <brief_title>A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Participants With Mild to Moderate COVID-19 Illness</brief_title>
  <acronym>BLAZE-1</acronym>
  <official_title>A Randomized, Double-blind, Placebo-Controlled, Phase 2/3 Study to Evaluate the Efficacy and Safety of LY3819253 and LY3832479 in Participants With Mild to Moderate COVID-19 Illness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AbCellera Biologics Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai Junshi Bioscience Co., Ltd.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Eli Lilly and Company</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to measure how well LY3819253 and LY3832479 work against the&#xD;
      virus that causes COVID-19. LY3819253 and LY3832479 will be given to participants with early&#xD;
      symptoms of COVID-19. Samples will be taken from the back of the nose to determine how much&#xD;
      virus is in the body at various times during the study. Participation could last about 12&#xD;
      weeks and includes one required visit to the study site, with the remainder of assessments&#xD;
      performed in the home or by phone.&#xD;
&#xD;
      Pediatric participants, with mild to moderate COVID-19 illness, will enroll in a single-arm&#xD;
      (Arm 23), open-label addendum to evaluate the pharmacokinetics and safety of LY3853113.&#xD;
      Enrollment began on August 19, 2022 and completed on February 21, 2023.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 17, 2020</start_date>
  <completion_date type="Actual">February 21, 2023</completion_date>
  <primary_completion_date type="Actual">February 21, 2023</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Some treatment arms are open label.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Phase 3: Percentage of Participants Who Experience COVID-Related Hospitalization or Death From Any Cause in 2800 mg Bamlanivumab/2800 mg Etesevimab, 700 mg Bamlanivimab/1400mg Etesevimab and Their Placebo Groups</measure>
    <time_frame>Baseline through Day 29</time_frame>
    <description>COVID-19 Related Deterioration (yes/no) was defined as a participant experiencing COVID-19-related hospitalization (defined as 24 hours of acute care) or death from any cause by Day 29.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phase 3: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than a Prespecified Threshold in Arms 350 mg Bamlanivimab/700 mg Etesevimab and Placebo</measure>
    <time_frame>Day 7</time_frame>
    <description>SARS-CoV-2 persistent high viral load (yes/no) was defined as ribonuclease P(RP) normalized viral load &gt;=5.27 vs otherwise.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phase 2: Change From Baseline to Day 11 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load</measure>
    <time_frame>Baseline, Day 11</time_frame>
    <description>SARS-CoV-2 viral load was based on nasopharyngeal swab sampling for reverse transcription polymerase chain reaction (RT-PCR) testing for SARS-CoV-2. Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. If Day 11 SARS-CoV-2 viral load was missing, the earliest measurement closest to the Day 11 visit, but within 4 days (Day 7-Day 15), was used for the Day 11 value. If no measurements were available, the Day 11 viral load was treated as missing at random (MAR) in the analysis.&#xD;
Viral load is reported as normalized viral load and is unitless.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phase 2: Percentage of Participants Who Experience a Serious Adverse Event(s) SAE(s)</measure>
    <time_frame>Baseline through Day 85</time_frame>
    <description>An SAE was defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect and other different situations will have medical or scientific judgment to determine if they are SAE. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality are reported in the Adverse Events section.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Phase 3: Percentage of Participants Demonstrating Symptom Resolution</measure>
    <time_frame>Day 11</time_frame>
    <description>Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and changes in taste and smell. Each symptom was scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Symptom resolution (yes/no) is defined as a score of 0 for shortness of breath, feeling feverish, body aches and pains, sore throat, chills, and headache; and a score of 0 or 1 for cough and fatigue on the symptom questionnaire (excluding the loss of appetite and changes in taste and smell symptoms). Missing data were imputed using non-responder imputation (NRI) method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 3: Percentage of Participants Demonstrating Symptom Improvement</measure>
    <time_frame>Day 11</time_frame>
    <description>Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and changes in taste and smell. Each symptom will be scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Symptom improvement was defined as a participant experiencing both: Symptoms on the symptom questionnaire scored as moderate or severe at baseline are subsequently scored as mild or absent, and symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent. Missing data were imputed using NRI method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 3: Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause</measure>
    <time_frame>Baseline through Day 85</time_frame>
    <description>COVID-19 Related Deterioration (yes/no) is defined as a patient experiencing COVID-19-related hospitalization, Emergency Room Visit, or Death from any causes vs otherwise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 3: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load</measure>
    <time_frame>Baseline, Day 7</time_frame>
    <description>Change from baseline to Day 7 (±2 days) in SARS-CoV-2 viral load was based on nasopharyngeal swab sampling for reverse transcription polymerase chain reaction (RT-PCR) testing for SARS-CoV-2. Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. If Day 7 SARS-CoV-2 viral load was missing, the earliest measurement closest to the Day 7 visit, but within 2 days (Day 5-Day 9), was used for the Day 7 value. If no measurements are available, the Day 7 viral load was treated as missing at random (MAR) in the analysis.&#xD;
Viral load is reported as normalized viral and is unitless.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 3: Time to Sustained Symptom Resolution</measure>
    <time_frame>Baseline through Day 29</time_frame>
    <description>Sustained symptom resolution was defined as 2 consecutive assessments with a score of 0 for shortness of breath, feeling feverish, body aches and pains, sore throat, chills, and headache; and a score of 0 or 1 for cough and fatigue on the symptom questionnaire. Participants who did not experience sustained symptom resolution by completion or early discontinuation of study were censored at the date of their last visit during. Additionally, participants who were hospitalized were censored at their date of hospitalization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 3: Time to SARS-CoV-2 Viral Clearance</measure>
    <time_frame>Baseline through Day 29</time_frame>
    <description>Participants who did not experience SARS-CoV-2 viral clearance by completion or early discontinuation of study were censored at the date of their last visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2: Change From Baseline to Day 11 in SARS-CoV-2 Viral Load Among Participants Enrolled With Recent Symptoms Prior to Randomization</measure>
    <time_frame>Baseline, Day 11</time_frame>
    <description>SARS-CoV-2 viral load was based on nasopharyngeal swab sampling for reverse transcription polymerase chain reaction (RT-PCR) testing for SARS-CoV-2. This analysis included only participants whose symptoms developed no more than 8 days prior to randomization. Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. If Day 11 SARS-CoV-2 viral load is missing, the earliest measurement closest to the Day 11 visit, but within 4 days (Day 7-Day 15), will be used for the Day 11 value. If no measurements are available, the Day 11 viral load will be treated as MAR in the analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2: Percentage of Participants Demonstrating Symptom Resolution</measure>
    <time_frame>Day 11</time_frame>
    <description>Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and changes in taste and smell. Each symptom will be scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Symptom resolution was defined as all symptoms (those scored 0-3) on the symptom questionnaire scored as absent (0). Symptom Resolution (yes/no) was defined as all symptoms (excluding the loss of appetite and changes in taste and smell symptoms) on the symptom questionnaire scored as absent vs otherwise.&#xD;
Missing data were imputed using non-responder imputation (NRI) method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2: Percentage of Participants Demonstrating Symptom Improvement</measure>
    <time_frame>Day 11</time_frame>
    <description>Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and changes in taste and smell. Each symptom will be scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Symptom improvement was defined as a participant experiencing both: Symptoms on the symptom questionnaire scored as moderate or severe at baseline are subsequently scored as mild or absent, and Symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent. Missing data were imputed using NRI method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2, Pharmacokinetics (PK): Mean Concentration of Bamlanivimab Alone and in the Presence of Etesevimab</measure>
    <time_frame>Day 29 Post-dose</time_frame>
    <description>(PK): Mean Concentration of Bamlanivimab alone and in the Presence of Etesevimab</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2, PK: Mean Concentration of Etesevimab in the Presence of Bamlanivimab</measure>
    <time_frame>Day 29 Post-dose</time_frame>
    <description>PK: Mean Concentration of Etesevimab in the Presence of Bamlanivimab</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2: Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause</measure>
    <time_frame>Baseline through Day 85</time_frame>
    <description>Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related ER Visit, or Death from Any Cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2: Time to SARS-CoV-2 Viral Clearance</measure>
    <time_frame>Baseline through Day 29</time_frame>
    <description>Participants who did not experience SARS-CoV-2 viral clearance by completion or early discontinuation of study were censored at the date of their last visit.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">3307</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>LY3819253</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>700 mg, 2800 mg, 7000 mg, LY3819253 administered intravenously (IV)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LY3819253 + LY3832479</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>350 mg, 700 mg, 2800 mg LY3819253 + 700 mg, 1400 mg, 2800 mg LY3832479 administered IV or subcutaneously (SQ)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LY3853113 Open Label Addenda Arm 23</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administered IV</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo administered IV</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LY3819253</intervention_name>
    <description>Administered IV</description>
    <arm_group_label>LY3819253</arm_group_label>
    <arm_group_label>LY3819253 + LY3832479</arm_group_label>
    <other_name>LY-CoV555</other_name>
    <other_name>Bamlanivimab</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LY3832479</intervention_name>
    <description>Administered IV</description>
    <arm_group_label>LY3819253 + LY3832479</arm_group_label>
    <other_name>LY-CoV016</other_name>
    <other_name>Etesevimab</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LY3853113</intervention_name>
    <description>Administered IV</description>
    <arm_group_label>LY3853113 Open Label Addenda Arm 23</arm_group_label>
    <other_name>bebtelovimab</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Administered IV</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Are currently not hospitalized. (Not applicable to participants in treatment arm 22.)&#xD;
&#xD;
          -  Have one or more mild or moderate COVID-19 symptoms: Fever, cough, sore throat,&#xD;
             malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with&#xD;
             exertion. (Not applicable to participants in treatment arm 22.)&#xD;
&#xD;
          -  Must have sample taken for test confirming viral infection no more than 3 days prior&#xD;
             to starting the drug infusion&#xD;
&#xD;
          -  Are males or females, including pregnant females who agree to contraceptive&#xD;
             requirements&#xD;
&#xD;
          -  Understand and agree to comply with planned study procedures&#xD;
&#xD;
          -  Agree to the collection of nasopharyngeal swabs and venous blood. (Not applicable to&#xD;
             participants in treatment arms 20-21.)&#xD;
&#xD;
          -  The participant or legally authorized representative give signed informed consent&#xD;
             and/or assent&#xD;
&#xD;
        Participants in treatment arms 7-9, 13-14, and 18-21 ONLY&#xD;
&#xD;
          -  Are greater than or equal to (≥)18 years of age and must satisfy at least one of the&#xD;
             following at the time of screening&#xD;
&#xD;
               -  Are pregnant&#xD;
&#xD;
               -  Are ≥65 years of age&#xD;
&#xD;
               -  Have a body mass index (BMI) ≥35&#xD;
&#xD;
               -  Have chronic kidney disease (CKD)&#xD;
&#xD;
               -  Have type 1 or type 2 diabetes&#xD;
&#xD;
               -  Have immunosuppressive disease&#xD;
&#xD;
               -  Are currently receiving immunosuppressive treatment or&#xD;
&#xD;
               -  Are ≥55 years of age AND have:&#xD;
&#xD;
                    -  cardiovascular disease (CVD), OR&#xD;
&#xD;
                    -  hypertension, OR&#xD;
&#xD;
                    -  chronic obstructive pulmonary disease (COPD) or other chronic respiratory&#xD;
                       disease&#xD;
&#xD;
          -  Are 12-17 years of age (inclusive) AND satisfy at least one of the following at the&#xD;
             time of screening&#xD;
&#xD;
               -  Are pregnant&#xD;
&#xD;
               -  Have a body mass index (BMI) ≥85th percentile for their age and gender based on&#xD;
                  CDC growth charts, https://www.cdc.gov/growthcharts/clinical_charts.htm&#xD;
&#xD;
               -  Have sickle cell disease&#xD;
&#xD;
               -  Have congenital or acquired heart disease&#xD;
&#xD;
               -  Have neurodevelopmental disorders, for example, cerebral palsy&#xD;
&#xD;
               -  Have a medical-related technological dependence, for example, tracheostomy,&#xD;
                  gastrostomy, or positive pressure ventilation (not related to COVID-19)&#xD;
&#xD;
               -  Have asthma or reactive airway or other chronic respiratory disease that requires&#xD;
                  daily medication for control&#xD;
&#xD;
               -  Have type 1 or type 2 diabetes&#xD;
&#xD;
               -  Have chronic kidney disease&#xD;
&#xD;
               -  Have immunosuppressive disease, or&#xD;
&#xD;
               -  Are currently receiving immunosuppressive treatment&#xD;
&#xD;
        Participants in treatment arm 22 ONLY&#xD;
&#xD;
        - Are 0 (≥ 32 weeks gestational age AND ≥ 1.5 kilograms [kg]) to 17 years of age&#xD;
        (inclusive) AND satisfy at least one of the following risk factors at the time of screening&#xD;
&#xD;
          -  Are pregnant&#xD;
&#xD;
          -  Have a BMI ≥85th percentile for their age and gender based on CDC growth charts,&#xD;
             https://www.cdc.gov/growthcharts/clinical_charts.htm&#xD;
&#xD;
          -  Have sickle cell disease&#xD;
&#xD;
          -  Have congenital or acquired heart disease&#xD;
&#xD;
          -  Have neurodevelopmental disorders, for example, cerebral palsy, autism, or Down&#xD;
             syndrome (FAIR Health 2020; Spreat et al. 2020)&#xD;
&#xD;
          -  Have a medical-related technological dependence, for example, tracheostomy,&#xD;
             gastrostomy, or positive pressure ventilation (not related to COVID-19)&#xD;
&#xD;
          -  Have asthma, cystic fibrosis, reactive airways disease or other chronic respiratory&#xD;
             disease that requires daily medication for control&#xD;
&#xD;
          -  Have type 1 or type 2 diabetes&#xD;
&#xD;
          -  Have chronic kidney disease&#xD;
&#xD;
          -  Have immunosuppressive disease, or&#xD;
&#xD;
          -  Are currently receiving immunosuppressive treatment, or&#xD;
&#xD;
          -  Are less than (&lt;) one year of age.&#xD;
&#xD;
          -  Have one or more COVID-19 symptoms&#xD;
&#xD;
               -  Shortness of breath/difficulty breathing&#xD;
&#xD;
               -  Fever&#xD;
&#xD;
               -  Sore throat&#xD;
&#xD;
               -  Nausea&#xD;
&#xD;
               -  Diarrhea&#xD;
&#xD;
               -  Tiredness&#xD;
&#xD;
               -  Headache&#xD;
&#xD;
               -  New loss of taste&#xD;
&#xD;
               -  Nasal congestion/runny nose&#xD;
&#xD;
               -  Chills&#xD;
&#xD;
               -  Stomachache&#xD;
&#xD;
               -  Vomiting&#xD;
&#xD;
               -  Cough&#xD;
&#xD;
               -  Muscle/body aches and pain&#xD;
&#xD;
               -  New loss of smell&#xD;
&#xD;
               -  Poor appetite or poor feeding (in babies)&#xD;
&#xD;
        Participants in treatment arm 23 ONLY:&#xD;
&#xD;
        Must have first positive result sample of current SARS-CoV-2 viral infection ≤3 days prior&#xD;
        to start of treatment administration.&#xD;
&#xD;
        Participant can have COVID previously and still meet criteria for this addendum. Positive&#xD;
        result needs to be from a current infection.&#xD;
&#xD;
        Are 0 (≥ 38 weeks gestational age and ≥ 3.3 kg) to &lt;12 years of age at the time of&#xD;
        screening, or are 12 to 17 and weighing &lt;40 kg; and&#xD;
&#xD;
          -  Have mild to moderate COVID-19 disease, including one or more COVID-19 symptoms within&#xD;
             the last 7 days&#xD;
&#xD;
          -  Shortness of breath/difficulty breathing&#xD;
&#xD;
          -  Fever&#xD;
&#xD;
          -  Sore throat&#xD;
&#xD;
          -  Nausea&#xD;
&#xD;
          -  Diarrhea&#xD;
&#xD;
          -  Tiredness&#xD;
&#xD;
          -  Headache&#xD;
&#xD;
          -  New loss of taste&#xD;
&#xD;
          -  Nasal congestion/runny nose&#xD;
&#xD;
          -  Chills&#xD;
&#xD;
          -  Malaise&#xD;
&#xD;
          -  Vomiting&#xD;
&#xD;
          -  Cough&#xD;
&#xD;
          -  Muscle/body aches and pain&#xD;
&#xD;
          -  New loss of smell&#xD;
&#xD;
          -  Poor appetite or poor feeding (in babies under 1 year old)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have oxygen saturation (SpO2) less than or equal to (≤)93 percent (%) on room air at&#xD;
             sea level or ratio of arterial oxygen partial pressure (PaO2 in millimeters of&#xD;
             mercury) to fractional inspired oxygen (FiO2) less than (&lt;)300, respiratory rate&#xD;
             greater than or equal to (≥)30 per minute, heart rate ≥125 per minute due to COVID-19&#xD;
&#xD;
          -  Require mechanical ventilation or anticipated impending need for mechanical&#xD;
             ventilation due to COVID-19&#xD;
&#xD;
          -  Have known allergies to any of the components used in the formulation of the&#xD;
             interventions&#xD;
&#xD;
          -  Have hemodynamic instability requiring use of pressors within 24 hours of&#xD;
             randomization&#xD;
&#xD;
          -  Suspected or proven serious, active bacterial, fungal, viral, or other infection&#xD;
             (besides COVID-19) that in the opinion of the investigator could constitute a risk&#xD;
             when taking intervention&#xD;
&#xD;
          -  Have any co-morbidity requiring surgery within &lt;7 days, or that is considered&#xD;
             life-threatening within 29 days&#xD;
&#xD;
          -  Have any serious concomitant systemic disease, condition or disorder that, in the&#xD;
             opinion of the investigator, should preclude participation in this study&#xD;
&#xD;
          -  Have a history of a positive SARS-CoV-2 test prior to the one serving as eligibility&#xD;
             for this study&#xD;
&#xD;
          -  Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30&#xD;
             days before dosing&#xD;
&#xD;
          -  Have received treatment with a SARS-CoV-2 specific monoclonal antibody&#xD;
&#xD;
          -  Have received convalescent COVID-19 plasma treatment&#xD;
&#xD;
          -  Have participated in a previous SARS-CoV-2 vaccine study or have received a SARS-CoV-2&#xD;
             vaccine&#xD;
&#xD;
          -  Have participated, within the last 30 days, in a clinical study involving an&#xD;
             investigational intervention. If the previous investigational intervention has a long&#xD;
             half-life, 5 half-lives or 30 days, whichever is longer, should have passed&#xD;
&#xD;
          -  Are concurrently enrolled in any other type of medical research judged not to be&#xD;
             scientifically or medically compatible with this study&#xD;
&#xD;
          -  Mothers who are breast feeding&#xD;
&#xD;
        Participants in Treatment Arm 22 ONLY&#xD;
&#xD;
          -  Have a diagnosis of Multisystem Inflammatory Syndrome in Children (MIS-C) in the&#xD;
             opinion of the investigator&#xD;
&#xD;
          -  Are currently hospitalized for treatment of COVID-19. Other reasons for&#xD;
             hospitalization are acceptable.&#xD;
&#xD;
        Participants in treatment arm 23 ONLY&#xD;
&#xD;
          -  SpO2 ≤ 93% on room air at sea level, or while on chronic oxygen therapy and/or&#xD;
             respiratory support due to underlying non-COVID-19 related comorbidity, respiratory&#xD;
             rate ≥30 per minute, and heart rate ≥125 per minute due to COVID-19 (FDA February&#xD;
             2021)&#xD;
&#xD;
          -  Require mechanical ventilation or anticipated impending need for mechanical&#xD;
             ventilation due to COVID-19&#xD;
&#xD;
          -  Have known allergies to any of the components used in the formulation of the&#xD;
             interventions&#xD;
&#xD;
          -  Have hemodynamic instability requiring use of pressors within 24 hours of&#xD;
             randomization&#xD;
&#xD;
          -  Suspected or proven serious, active bacterial, fungal, viral, or other infection&#xD;
             (besides COVID-19) that in the opinion of the investigator could constitute a risk&#xD;
             when taking intervention&#xD;
&#xD;
          -  Have any co-morbidity requiring surgery within 7 days, or that is considered&#xD;
             life-threatening within 29 days&#xD;
&#xD;
          -  Have any serious concomitant systemic disease, condition or disorder that, in the&#xD;
             opinion of the investigator, should preclude participation in this study.&#xD;
&#xD;
          -  Have received treatment with a SARS-CoV-2 specific monoclonal antibody or remdesivir&#xD;
             within 90 days before dosing.&#xD;
&#xD;
          -  Have received convalescent COVID-19 plasma treatment within 90 days before dosing&#xD;
&#xD;
          -  Have participated, within the last 30 days, in a clinical study involving an&#xD;
             investigational intervention. If the previous investigational intervention has a long&#xD;
             half-life, 5 half-lives or 30 days, whichever is longer, should have passed&#xD;
&#xD;
          -  Are concurrently enrolled in any other type of medical research judged not to be&#xD;
             scientifically or medically compatible with this study&#xD;
&#xD;
          -  Are currently pregnant or breast feeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>0 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)</last_name>
    <role>Study Director</role>
    <affiliation>Eli Lilly and Company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinnova Research - Redondo Beach</name>
      <address>
        <city>Redondo Beach</city>
        <state>California</state>
        <zip>90277</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bio-Medical Research, LLC</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33184</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rophe Adult and Pediatric Medicine</name>
      <address>
        <city>Union City</city>
        <state>Georgia</state>
        <zip>30291</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>U of MA Mem Med Ctr</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01655</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Great Lakes Research Group, Inc.</name>
      <address>
        <city>Bay City</city>
        <state>Michigan</state>
        <zip>48706</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Childrens Hospital of Michigan</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sky Clinical Prime and Health Wellness Clinic</name>
      <address>
        <city>Fayette</city>
        <state>Mississippi</state>
        <zip>39069</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sky Clin Resch - Quinn HC</name>
      <address>
        <city>Ridgeland</city>
        <state>Mississippi</state>
        <zip>39157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Monroe Biomed Research</name>
      <address>
        <city>Monroe</city>
        <state>North Carolina</state>
        <zip>28112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>B S &amp; W Med Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Research Institute</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Puerto Rico</country>
  </removed_countries>
  <link>
    <url>https://trials.lillytrialguide.com/en-US/trial/63aASRmBPQCBCOfy5oO0er</url>
    <description>A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Participants With Mild to Moderate COVID-19 Illness (BLAZE-1)</description>
  </link>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <results_first_submitted>February 14, 2022</results_first_submitted>
  <results_first_submitted_qc>February 14, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">March 7, 2022</results_first_posted>
  <last_update_submitted>April 17, 2023</last_update_submitted>
  <last_update_submitted_qc>April 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>Bamlanivimab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting</ipd_time_frame>
    <ipd_access_criteria>Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting</ipd_access_criteria>
    <ipd_url>http://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 2, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/01/NCT04427501/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 17, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/01/NCT04427501/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>This study has three parts: Phase 2, Phase 3 and pediatrics addendum. Pediatrics addendum data are going to be reported with end of trial data.&#xD;
All participants in Placebo for Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab are also in Placebo For Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab therefore the two arms are combined to avoid double counting.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Phase 2: Placebo</title>
          <description>Participants received Placebo administered intravenously (IV).</description>
        </group>
        <group group_id="P2">
          <title>Phase 2: 700 mg Bamlanivimab</title>
          <description>Participants received 700 milligram (mg) bamlanivimab administered IV.</description>
        </group>
        <group group_id="P3">
          <title>Phase 2: 2800 mg Bamlanivimab</title>
          <description>Participants received 2800 mg bamlanivimab administered IV.</description>
        </group>
        <group group_id="P4">
          <title>Phase 2: 7000 mg Bamlanivimab</title>
          <description>Participants received 7000 mg bamlanivimab administered IV.</description>
        </group>
        <group group_id="P5">
          <title>Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab</title>
          <description>Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.</description>
        </group>
        <group group_id="P6">
          <title>Phase 3: Placebo</title>
          <description>Participants received Placebo administered intravenously (IV).</description>
        </group>
        <group group_id="P7">
          <title>Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab</title>
          <description>Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.</description>
        </group>
        <group group_id="P8">
          <title>Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab</title>
          <description>Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.</description>
        </group>
        <group group_id="P9">
          <title>Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab</title>
          <description>Participants received Placebo administered intravenously (IV).</description>
        </group>
        <group group_id="P10">
          <title>Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab</title>
          <description>Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="156"/>
                <participants group_id="P2" count="101"/>
                <participants group_id="P3" count="107"/>
                <participants group_id="P4" count="101"/>
                <participants group_id="P5" count="112"/>
                <participants group_id="P6" count="776">Participants in Placebo for Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab and Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab were combined to avoid double counting.</participants>
                <participants group_id="P7" count="518"/>
                <participants group_id="P8" count="513"/>
                <participants group_id="P9" count="141"/>
                <participants group_id="P10" count="213"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least One Dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="156"/>
                <participants group_id="P2" count="101"/>
                <participants group_id="P3" count="107"/>
                <participants group_id="P4" count="101"/>
                <participants group_id="P5" count="112"/>
                <participants group_id="P6" count="776"/>
                <participants group_id="P7" count="518"/>
                <participants group_id="P8" count="513"/>
                <participants group_id="P9" count="141"/>
                <participants group_id="P10" count="213"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="517"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="776"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="141"/>
                <participants group_id="P2" count="95"/>
                <participants group_id="P3" count="103"/>
                <participants group_id="P4" count="98"/>
                <participants group_id="P5" count="103"/>
                <participants group_id="P6" count="719"/>
                <participants group_id="P7" count="485"/>
                <participants group_id="P8" count="496"/>
                <participants group_id="P9" count="135"/>
                <participants group_id="P10" count="207"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="9"/>
                <participants group_id="P6" count="57"/>
                <participants group_id="P7" count="33"/>
                <participants group_id="P8" count="17"/>
                <participants group_id="P9" count="6"/>
                <participants group_id="P10" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="15"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="11"/>
                <participants group_id="P7" count="10"/>
                <participants group_id="P8" count="10"/>
                <participants group_id="P9" count="2"/>
                <participants group_id="P10" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="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="2"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="7"/>
                <participants group_id="P6" count="25"/>
                <participants group_id="P7" count="15"/>
                <participants group_id="P8" count="7"/>
                <participants group_id="P9" count="4"/>
                <participants group_id="P10" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other - as reported by the investigator</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="6"/>
                <participants group_id="P7" count="6"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All randomized participants who received at least one dose of study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>Phase 2: Placebo</title>
          <description>Participants received Placebo administered intravenously (IV).</description>
        </group>
        <group group_id="B2">
          <title>Phase 2: 700 mg Bamlanivimab</title>
          <description>Participants received 700 mg bamlanivimab administered IV.</description>
        </group>
        <group group_id="B3">
          <title>Phase 2: 2800 mg Bamlanivimab</title>
          <description>Participants received 2800 mg bamlanivimab administered IV.</description>
        </group>
        <group group_id="B4">
          <title>Phase 2: 7000 mg Bamlanivimab</title>
          <description>Participants received 7000 mg bamlanivimab administered IV.</description>
        </group>
        <group group_id="B5">
          <title>Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab</title>
          <description>Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.</description>
        </group>
        <group group_id="B6">
          <title>Phase 3: Placebo</title>
          <description>Participants received Placebo administered intravenously (IV).</description>
        </group>
        <group group_id="B7">
          <title>Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab</title>
          <description>Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.</description>
        </group>
        <group group_id="B8">
          <title>Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab</title>
          <description>Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.</description>
        </group>
        <group group_id="B9">
          <title>Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab</title>
          <description>Participants received Placebo administered intravenously (IV).</description>
        </group>
        <group group_id="B10">
          <title>Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab</title>
          <description>Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.</description>
        </group>
        <group group_id="B11">
          <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="156"/>
            <count group_id="B2" value="101"/>
            <count group_id="B3" value="107"/>
            <count group_id="B4" value="101"/>
            <count group_id="B5" value="112"/>
            <count group_id="B6" value="776"/>
            <count group_id="B7" value="518"/>
            <count group_id="B8" value="513"/>
            <count group_id="B9" value="141"/>
            <count group_id="B10" value="213"/>
            <count group_id="B11" value="2738"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="156"/>
                    <count group_id="B2" value="101"/>
                    <count group_id="B3" value="107"/>
                    <count group_id="B4" value="101"/>
                    <count group_id="B5" value="112"/>
                    <count group_id="B6" value="776"/>
                    <count group_id="B7" value="518"/>
                    <count group_id="B8" value="513"/>
                    <count group_id="B9" value="141"/>
                    <count group_id="B10" value="213"/>
                    <count group_id="B11" value="2738"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45.7" spread="15.38"/>
                    <measurement group_id="B2" value="43.5" spread="16.21"/>
                    <measurement group_id="B3" value="44.4" spread="14.61"/>
                    <measurement group_id="B4" value="45.7" spread="16.28"/>
                    <measurement group_id="B5" value="43.9" spread="16.39"/>
                    <measurement group_id="B6" value="53.4" spread="16.52"/>
                    <measurement group_id="B7" value="54.3" spread="17.08"/>
                    <measurement group_id="B8" value="54.5" spread="16.77"/>
                    <measurement group_id="B9" value="53.6" spread="15.70"/>
                    <measurement group_id="B10" value="52.7" spread="17.49"/>
                    <measurement group_id="B11" value="51.9" spread="16.95"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="156"/>
                    <count group_id="B2" value="101"/>
                    <count group_id="B3" value="107"/>
                    <count group_id="B4" value="101"/>
                    <count group_id="B5" value="112"/>
                    <count group_id="B6" value="776"/>
                    <count group_id="B7" value="518"/>
                    <count group_id="B8" value="513"/>
                    <count group_id="B9" value="141"/>
                    <count group_id="B10" value="213"/>
                    <count group_id="B11" value="2738"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="85"/>
                    <measurement group_id="B2" value="63"/>
                    <measurement group_id="B3" value="51"/>
                    <measurement group_id="B4" value="58"/>
                    <measurement group_id="B5" value="58"/>
                    <measurement group_id="B6" value="404"/>
                    <measurement group_id="B7" value="279"/>
                    <measurement group_id="B8" value="265"/>
                    <measurement group_id="B9" value="68"/>
                    <measurement group_id="B10" value="108"/>
                    <measurement group_id="B11" value="1439"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="71"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="56"/>
                    <measurement group_id="B4" value="43"/>
                    <measurement group_id="B5" value="54"/>
                    <measurement group_id="B6" value="372"/>
                    <measurement group_id="B7" value="239"/>
                    <measurement group_id="B8" value="248"/>
                    <measurement group_id="B9" value="73"/>
                    <measurement group_id="B10" value="105"/>
                    <measurement group_id="B11" value="1299"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="156"/>
                    <count group_id="B2" value="101"/>
                    <count group_id="B3" value="107"/>
                    <count group_id="B4" value="101"/>
                    <count group_id="B5" value="112"/>
                    <count group_id="B6" value="776"/>
                    <count group_id="B7" value="518"/>
                    <count group_id="B8" value="513"/>
                    <count group_id="B9" value="141"/>
                    <count group_id="B10" value="213"/>
                    <count group_id="B11" value="2738"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="69"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="47"/>
                    <measurement group_id="B4" value="39"/>
                    <measurement group_id="B5" value="42"/>
                    <measurement group_id="B6" value="226"/>
                    <measurement group_id="B7" value="149"/>
                    <measurement group_id="B8" value="139"/>
                    <measurement group_id="B9" value="36"/>
                    <measurement group_id="B10" value="53"/>
                    <measurement group_id="B11" value="849"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="87"/>
                    <measurement group_id="B2" value="52"/>
                    <measurement group_id="B3" value="60"/>
                    <measurement group_id="B4" value="62"/>
                    <measurement group_id="B5" value="70"/>
                    <measurement group_id="B6" value="548"/>
                    <measurement group_id="B7" value="368"/>
                    <measurement group_id="B8" value="373"/>
                    <measurement group_id="B9" value="104"/>
                    <measurement group_id="B10" value="160"/>
                    <measurement group_id="B11" value="1884"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="1"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="156"/>
                    <count group_id="B2" value="101"/>
                    <count group_id="B3" value="107"/>
                    <count group_id="B4" value="101"/>
                    <count group_id="B5" value="112"/>
                    <count group_id="B6" value="776"/>
                    <count group_id="B7" value="518"/>
                    <count group_id="B8" value="513"/>
                    <count group_id="B9" value="141"/>
                    <count group_id="B10" value="213"/>
                    <count group_id="B11" value="2738"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="3"/>
                    <measurement group_id="B9" value="2"/>
                    <measurement group_id="B10" value="3"/>
                    <measurement group_id="B11" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="33"/>
                    <measurement group_id="B7" value="16"/>
                    <measurement group_id="B8" value="18"/>
                    <measurement group_id="B9" value="6"/>
                    <measurement group_id="B10" value="6"/>
                    <measurement group_id="B11" value="98"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="61"/>
                    <measurement group_id="B7" value="44"/>
                    <measurement group_id="B8" value="41"/>
                    <measurement group_id="B9" value="16"/>
                    <measurement group_id="B10" value="28"/>
                    <measurement group_id="B11" value="223"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="133"/>
                    <measurement group_id="B2" value="90"/>
                    <measurement group_id="B3" value="90"/>
                    <measurement group_id="B4" value="89"/>
                    <measurement group_id="B5" value="105"/>
                    <measurement group_id="B6" value="667"/>
                    <measurement group_id="B7" value="449"/>
                    <measurement group_id="B8" value="445"/>
                    <measurement group_id="B9" value="116"/>
                    <measurement group_id="B10" value="175"/>
                    <measurement group_id="B11" value="2359"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="7"/>
                    <measurement group_id="B7" value="6"/>
                    <measurement group_id="B8" value="3"/>
                    <measurement group_id="B9" value="1"/>
                    <measurement group_id="B10" value="1"/>
                    <measurement group_id="B11" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="156"/>
                    <count group_id="B2" value="101"/>
                    <count group_id="B3" value="107"/>
                    <count group_id="B4" value="101"/>
                    <count group_id="B5" value="112"/>
                    <count group_id="B6" value="776"/>
                    <count group_id="B7" value="518"/>
                    <count group_id="B8" value="513"/>
                    <count group_id="B9" value="141"/>
                    <count group_id="B10" value="213"/>
                    <count group_id="B11" value="2738"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="156"/>
                    <measurement group_id="B2" value="101"/>
                    <measurement group_id="B3" value="107"/>
                    <measurement group_id="B4" value="101"/>
                    <measurement group_id="B5" value="112"/>
                    <measurement group_id="B6" value="776"/>
                    <measurement group_id="B7" value="518"/>
                    <measurement group_id="B8" value="513"/>
                    <measurement group_id="B9" value="141"/>
                    <measurement group_id="B10" value="213"/>
                    <measurement group_id="B11" value="2738"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>SARS-CoV-2 Viral Load</title>
          <population>All participants who received at least one dose of study drug and had at least 1 post-baseline viral load measurement. Cycle threshold (Ct) denotes how many PCR cycles are required before the SARS-CoV-2 viral RNA reached a detectable level. Higher Ct values correspond to a lower viral load.</population>
          <units>Cycle threshold (Ct)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="152"/>
                    <count group_id="B2" value="101"/>
                    <count group_id="B3" value="107"/>
                    <count group_id="B4" value="101"/>
                    <count group_id="B5" value="109"/>
                    <count group_id="B6" value="774"/>
                    <count group_id="B7" value="508"/>
                    <count group_id="B8" value="510"/>
                    <count group_id="B9" value="141"/>
                    <count group_id="B10" value="213"/>
                    <count group_id="B11" value="2716"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23.79" spread="7.78"/>
                    <measurement group_id="B2" value="23.80" spread="6.55"/>
                    <measurement group_id="B3" value="24.47" spread="7.61"/>
                    <measurement group_id="B4" value="23.42" spread="6.78"/>
                    <measurement group_id="B5" value="22.72" spread="8.01"/>
                    <measurement group_id="B6" value="24.26" spread="8.194"/>
                    <measurement group_id="B7" value="23.98" spread="8.22"/>
                    <measurement group_id="B8" value="24.15" spread="7.28"/>
                    <measurement group_id="B9" value="24.29" spread="6.82"/>
                    <measurement group_id="B10" value="25.62" spread="7.33"/>
                    <measurement group_id="B11" value="24.16" spread="7.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Phase 3: Percentage of Participants Who Experience COVID-Related Hospitalization or Death From Any Cause in 2800 mg Bamlanivumab/2800 mg Etesevimab, 700 mg Bamlanivimab/1400mg Etesevimab and Their Placebo Groups</title>
        <description>COVID-19 Related Deterioration (yes/no) was defined as a participant experiencing COVID-19-related hospitalization (defined as 24 hours of acute care) or death from any cause by Day 29.</description>
        <time_frame>Baseline through Day 29</time_frame>
        <population>Phase 3: All randomized participants who received at least one dose of study drug and had COVID-related hospitalization or death from any cause data available in arms Placebo, 2800 mg Bamlanivimab + 2800 mg Etesevimab and 700 mg Bamlanivimab + 1400 mg Etesevimab.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab</title>
            <description>Participants received Placebo administered intravenously (IV).</description>
          </group>
          <group group_id="O2">
            <title>Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab</title>
            <description>Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.</description>
          </group>
          <group group_id="O3">
            <title>Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab</title>
            <description>Participants received Placebo administered intravenously (IV).</description>
          </group>
          <group group_id="O4">
            <title>Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab</title>
            <description>Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 3: Percentage of Participants Who Experience COVID-Related Hospitalization or Death From Any Cause in 2800 mg Bamlanivumab/2800 mg Etesevimab, 700 mg Bamlanivimab/1400mg Etesevimab and Their Placebo Groups</title>
          <description>COVID-19 Related Deterioration (yes/no) was defined as a participant experiencing COVID-19-related hospitalization (defined as 24 hours of acute care) or death from any cause by Day 29.</description>
          <population>Phase 3: All randomized participants who received at least one dose of study drug and had COVID-related hospitalization or death from any cause data available in arms Placebo, 2800 mg Bamlanivimab + 2800 mg Etesevimab and 700 mg Bamlanivimab + 1400 mg Etesevimab.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="517"/>
                <count group_id="O2" value="518"/>
                <count group_id="O3" value="776"/>
                <count group_id="O4" value="511"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.0" lower_limit="4.8" upper_limit="9.2"/>
                    <measurement group_id="O2" value="2.1" lower_limit="0.9" upper_limit="3.4"/>
                    <measurement group_id="O3" value="6.8" lower_limit="5.1" upper_limit="8.6"/>
                    <measurement group_id="O4" value="0.8" lower_limit="0.0" upper_limit="1.5"/>
                  </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>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.30</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.15</ci_lower_limit>
            <ci_upper_limit>0.58</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>
            <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>0.04</ci_lower_limit>
            <ci_upper_limit>0.31</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Phase 3: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than a Prespecified Threshold in Arms 350 mg Bamlanivimab/700 mg Etesevimab and Placebo</title>
        <description>SARS-CoV-2 persistent high viral load (yes/no) was defined as ribonuclease P(RP) normalized viral load &gt;=5.27 vs otherwise.</description>
        <time_frame>Day 7</time_frame>
        <population>Phase 3: All randomized participants who received at least one dose of study drug and had non-missing viral load values in arms Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab and 350 mg Bamlanivimab + 700 mg Etesevimab</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab</title>
            <description>Participants received Placebo administered intravenously (IV).</description>
          </group>
          <group group_id="O2">
            <title>Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab</title>
            <description>Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 3: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than a Prespecified Threshold in Arms 350 mg Bamlanivimab/700 mg Etesevimab and Placebo</title>
          <description>SARS-CoV-2 persistent high viral load (yes/no) was defined as ribonuclease P(RP) normalized viral load &gt;=5.27 vs otherwise.</description>
          <population>Phase 3: All randomized participants who received at least one dose of study drug and had non-missing viral load values in arms Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab and 350 mg Bamlanivimab + 700 mg Etesevimab</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="141"/>
                <count group_id="O2" value="213"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.8" lower_limit="26.9" upper_limit="42.6"/>
                    <measurement group_id="O2" value="10.8" lower_limit="6.6" upper_limit="15.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.23</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.13</ci_lower_limit>
            <ci_upper_limit>0.40</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Phase 2: Change From Baseline to Day 11 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load</title>
        <description>SARS-CoV-2 viral load was based on nasopharyngeal swab sampling for reverse transcription polymerase chain reaction (RT-PCR) testing for SARS-CoV-2. Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. If Day 11 SARS-CoV-2 viral load was missing, the earliest measurement closest to the Day 11 visit, but within 4 days (Day 7-Day 15), was used for the Day 11 value. If no measurements were available, the Day 11 viral load was treated as missing at random (MAR) in the analysis.&#xD;
Viral load is reported as normalized viral load and is unitless.</description>
        <time_frame>Baseline, Day 11</time_frame>
        <population>Phase 2: All randomized participants who received at least one dose of study drug and had a baseline and day 11 viral load value.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: Placebo</title>
            <description>Participants received Placebo administered intravenously (IV).</description>
          </group>
          <group group_id="O2">
            <title>Phase 2: 700 mg Bamlanivimab</title>
            <description>Participants received 700 mg bamlanivimab administered IV.</description>
          </group>
          <group group_id="O3">
            <title>Phase 2: 2800 mg Bamlanivimab</title>
            <description>Participants received 2800 mg bamlanivimab administered IV.</description>
          </group>
          <group group_id="O4">
            <title>Phase 2: 7000 mg Bamlanivimab</title>
            <description>Participants received 7000 mg bamlanivimab administered IV.</description>
          </group>
          <group group_id="O5">
            <title>Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab</title>
            <description>Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 2: Change From Baseline to Day 11 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load</title>
          <description>SARS-CoV-2 viral load was based on nasopharyngeal swab sampling for reverse transcription polymerase chain reaction (RT-PCR) testing for SARS-CoV-2. Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. If Day 11 SARS-CoV-2 viral load was missing, the earliest measurement closest to the Day 11 visit, but within 4 days (Day 7-Day 15), was used for the Day 11 value. If no measurements were available, the Day 11 viral load was treated as missing at random (MAR) in the analysis.&#xD;
Viral load is reported as normalized viral load and is unitless.</description>
          <population>Phase 2: All randomized participants who received at least one dose of study drug and had a baseline and day 11 viral load value.</population>
          <units>unitless</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="146"/>
                <count group_id="O2" value="100"/>
                <count group_id="O3" value="103"/>
                <count group_id="O4" value="95"/>
                <count group_id="O5" value="102"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.80" spread="0.141"/>
                    <measurement group_id="O2" value="-3.72" spread="0.170"/>
                    <measurement group_id="O3" value="-4.08" spread="0.168"/>
                    <measurement group_id="O4" value="-3.49" spread="0.175"/>
                    <measurement group_id="O5" value="-4.37" spread="0.169"/>
                  </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>0.6921</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.09</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.221</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.35</ci_lower_limit>
            <ci_upper_limit>0.52</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2110</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.27</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.219</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.71</ci_lower_limit>
            <ci_upper_limit>0.16</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1630</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.31</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.225</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.13</ci_lower_limit>
            <ci_upper_limit>0.76</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0099</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.57</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.220</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.00</ci_lower_limit>
            <ci_upper_limit>-0.14</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Phase 2: Percentage of Participants Who Experience a Serious Adverse Event(s) SAE(s)</title>
        <description>An SAE was defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect and other different situations will have medical or scientific judgment to determine if they are SAE. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality are reported in the Adverse Events section.</description>
        <time_frame>Baseline through Day 85</time_frame>
        <population>Phase 2: All randomized participants who received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 2: Placebo</title>
            <description>Participants received Placebo administered intravenously (IV).</description>
          </group>
          <group group_id="O2">
            <title>Phase 2: 700 mg Bamlanivimab</title>
            <description>Participants received 700 mg bamlanivimab administered IV.</description>
          </group>
          <group group_id="O3">
            <title>Phase 2: 2800 mg Bamlanivimab</title>
            <description>Participants received 2800 mg bamlanivimab administered IV.</description>
          </group>
          <group group_id="O4">
            <title>Phase 2: 7000 mg Bamlanivimab</title>
            <description>Participants received 7000 mg bamlanivimab administered IV.</description>
          </group>
          <group group_id="O5">
            <title>Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab</title>
            <description>Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 2: Percentage of Participants Who Experience a Serious Adverse Event(s) SAE(s)</title>
          <description>An SAE was defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect and other different situations will have medical or scientific judgment to determine if they are SAE. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality are reported in the Adverse Events section.</description>
          <population>Phase 2: All randomized participants who received at least one dose of study drug.</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="156"/>
                <count group_id="O2" value="101"/>
                <count group_id="O3" value="107"/>
                <count group_id="O4" value="101"/>
                <count group_id="O5" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 3: Percentage of Participants Demonstrating Symptom Resolution</title>
        <description>Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and changes in taste and smell. Each symptom was scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Symptom resolution (yes/no) is defined as a score of 0 for shortness of breath, feeling feverish, body aches and pains, sore throat, chills, and headache; and a score of 0 or 1 for cough and fatigue on the symptom questionnaire (excluding the loss of appetite and changes in taste and smell symptoms). Missing data were imputed using non-responder imputation (NRI) method.</description>
        <time_frame>Day 11</time_frame>
        <population>Phase 3: All randomized participants who received at least one dose of study drug and had non-missing Symptom Resolution values</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab</title>
            <description>Participants received Placebo administered intravenously (IV).</description>
          </group>
          <group group_id="O2">
            <title>Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab</title>
            <description>Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.</description>
          </group>
          <group group_id="O3">
            <title>Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab</title>
            <description>Participants received Placebo administered intravenously (IV).</description>
          </group>
          <group group_id="O4">
            <title>Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab</title>
            <description>Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.</description>
          </group>
          <group group_id="O5">
            <title>Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab</title>
            <description>Participants received Placebo administered intravenously (IV).</description>
          </group>
          <group group_id="O6">
            <title>Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab</title>
            <description>Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 3: Percentage of Participants Demonstrating Symptom Resolution</title>
          <description>Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and changes in taste and smell. Each symptom was scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Symptom resolution (yes/no) is defined as a score of 0 for shortness of breath, feeling feverish, body aches and pains, sore throat, chills, and headache; and a score of 0 or 1 for cough and fatigue on the symptom questionnaire (excluding the loss of appetite and changes in taste and smell symptoms). Missing data were imputed using non-responder imputation (NRI) method.</description>
          <population>Phase 3: All randomized participants who received at least one dose of study drug and had non-missing Symptom Resolution values</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="499"/>
                <count group_id="O2" value="508"/>
                <count group_id="O3" value="774"/>
                <count group_id="O4" value="510"/>
                <count group_id="O5" value="141"/>
                <count group_id="O6" value="213"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.1" lower_limit="47.7" upper_limit="56.5"/>
                    <measurement group_id="O2" value="61.2" lower_limit="57.0" upper_limit="65.5"/>
                    <measurement group_id="O3" value="50.9" lower_limit="47.4" upper_limit="54.4"/>
                    <measurement group_id="O4" value="61.8" lower_limit="57.5" upper_limit="66.0"/>
                    <measurement group_id="O5" value="51.8" lower_limit="43.5" upper_limit="60.0"/>
                    <measurement group_id="O6" value="63.8" lower_limit="57.4" upper_limit="70.3"/>
                  </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>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.45</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.13</ci_lower_limit>
            <ci_upper_limit>1.86</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>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.56</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.24</ci_lower_limit>
            <ci_upper_limit>1.95</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.64</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.06</ci_lower_limit>
            <ci_upper_limit>2.53</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 3: Percentage of Participants Demonstrating Symptom Improvement</title>
        <description>Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and changes in taste and smell. Each symptom will be scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Symptom improvement was defined as a participant experiencing both: Symptoms on the symptom questionnaire scored as moderate or severe at baseline are subsequently scored as mild or absent, and symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent. Missing data were imputed using NRI method.</description>
        <time_frame>Day 11</time_frame>
        <population>Phase 3: All randomized participants who received at least one dose of study drug and had non-missing Symptom Improvement values</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab</title>
            <description>Participants received Placebo administered intravenously (IV).</description>
          </group>
          <group group_id="O2">
            <title>Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab</title>
            <description>Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.</description>
          </group>
          <group group_id="O3">
            <title>Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab</title>
            <description>Participants received Placebo administered intravenously (IV).</description>
          </group>
          <group group_id="O4">
            <title>Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab</title>
            <description>Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.</description>
          </group>
          <group group_id="O5">
            <title>Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab</title>
            <description>Participants received Placebo administered intravenously (IV).</description>
          </group>
          <group group_id="O6">
            <title>Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab</title>
            <description>Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 3: Percentage of Participants Demonstrating Symptom Improvement</title>
          <description>Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and changes in taste and smell. Each symptom will be scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Symptom improvement was defined as a participant experiencing both: Symptoms on the symptom questionnaire scored as moderate or severe at baseline are subsequently scored as mild or absent, and symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent. Missing data were imputed using NRI method.</description>
          <population>Phase 3: All randomized participants who received at least one dose of study drug and had non-missing Symptom Improvement values</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="499"/>
                <count group_id="O2" value="508"/>
                <count group_id="O3" value="774"/>
                <count group_id="O4" value="510"/>
                <count group_id="O5" value="141"/>
                <count group_id="O6" value="213"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.9" lower_limit="36.6" upper_limit="45.2"/>
                    <measurement group_id="O2" value="51.0" lower_limit="46.6" upper_limit="55.3"/>
                    <measurement group_id="O3" value="40.1" lower_limit="36.6" upper_limit="43.5"/>
                    <measurement group_id="O4" value="52.7" lower_limit="48.4" upper_limit="57.1"/>
                    <measurement group_id="O5" value="38.3" lower_limit="30.3" upper_limit="46.3"/>
                    <measurement group_id="O6" value="54.0" lower_limit="47.3" upper_limit="60.7"/>
                  </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>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.50</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.17</ci_lower_limit>
            <ci_upper_limit>1.93</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>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.67</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.33</ci_lower_limit>
            <ci_upper_limit>2.09</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.88</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.22</ci_lower_limit>
            <ci_upper_limit>2.9</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 3: Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause</title>
        <description>COVID-19 Related Deterioration (yes/no) is defined as a patient experiencing COVID-19-related hospitalization, Emergency Room Visit, or Death from any causes vs otherwise.</description>
        <time_frame>Baseline through Day 85</time_frame>
        <population>Phase 3: All randomized participants who received at least one dose of study drug and had COVID-related hospitalization, COVID-Related Emergency Room (ER) Visit, or death from any cause data available.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab</title>
            <description>Participants received Placebo administered intravenously (IV).</description>
          </group>
          <group group_id="O2">
            <title>Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab</title>
            <description>Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.</description>
          </group>
          <group group_id="O3">
            <title>Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab</title>
            <description>Participants received Placebo administered intravenously (IV).</description>
          </group>
          <group group_id="O4">
            <title>Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab</title>
            <description>Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.</description>
          </group>
          <group group_id="O5">
            <title>Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab</title>
            <description>Participants received Placebo administered intravenously (IV).</description>
          </group>
          <group group_id="O6">
            <title>Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab</title>
            <description>Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 3: Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause</title>
          <description>COVID-19 Related Deterioration (yes/no) is defined as a patient experiencing COVID-19-related hospitalization, Emergency Room Visit, or Death from any causes vs otherwise.</description>
          <population>Phase 3: All randomized participants who received at least one dose of study drug and had COVID-related hospitalization, COVID-Related Emergency Room (ER) Visit, or death from any cause data available.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="517"/>
                <count group_id="O2" value="518"/>
                <count group_id="O3" value="716"/>
                <count group_id="O4" value="511"/>
                <count group_id="O5" value="141"/>
                <count group_id="O6" value="231"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.2" lower_limit="4.9" upper_limit="9.4"/>
                    <measurement group_id="O2" value="2.5" lower_limit="1.2" upper_limit="3.9"/>
                    <measurement group_id="O3" value="7.0" lower_limit="5.2" upper_limit="8.7"/>
                    <measurement group_id="O4" value="1.2" lower_limit="0.2" upper_limit="2.1"/>
                    <measurement group_id="O5" value="4.3" lower_limit="0.9" upper_limit="7.6"/>
                    <measurement group_id="O6" value="0.9" lower_limit="0.0" upper_limit="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.34</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.18</ci_lower_limit>
            <ci_upper_limit>0.64</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>
            <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>0.07</ci_lower_limit>
            <ci_upper_limit>0.38</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.25</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.06</ci_lower_limit>
            <ci_upper_limit>1.05</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 3: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load</title>
        <description>Change from baseline to Day 7 (±2 days) in SARS-CoV-2 viral load was based on nasopharyngeal swab sampling for reverse transcription polymerase chain reaction (RT-PCR) testing for SARS-CoV-2. Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. If Day 7 SARS-CoV-2 viral load was missing, the earliest measurement closest to the Day 7 visit, but within 2 days (Day 5-Day 9), was used for the Day 7 value. If no measurements are available, the Day 7 viral load was treated as missing at random (MAR) in the analysis.&#xD;
Viral load is reported as normalized viral and is unitless.</description>
        <time_frame>Baseline, Day 7</time_frame>
        <population>Phase 3: All randomized participants who received at least one dose of study drug and had a baseline and day 7 viral load value.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab</title>
            <description>Participants received Placebo administered intravenously (IV).</description>
          </group>
          <group group_id="O2">
            <title>Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab</title>
            <description>Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.</description>
          </group>
          <group group_id="O3">
            <title>Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab</title>
            <description>Participants received Placebo administered intravenously (IV).</description>
          </group>
          <group group_id="O4">
            <title>Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab</title>
            <description>Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.</description>
          </group>
          <group group_id="O5">
            <title>Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab</title>
            <description>Participants received Placebo administered intravenously (IV).</description>
          </group>
          <group group_id="O6">
            <title>Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab</title>
            <description>Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 3: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load</title>
          <description>Change from baseline to Day 7 (±2 days) in SARS-CoV-2 viral load was based on nasopharyngeal swab sampling for reverse transcription polymerase chain reaction (RT-PCR) testing for SARS-CoV-2. Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. If Day 7 SARS-CoV-2 viral load was missing, the earliest measurement closest to the Day 7 visit, but within 2 days (Day 5-Day 9), was used for the Day 7 value. If no measurements are available, the Day 7 viral load was treated as missing at random (MAR) in the analysis.&#xD;
Viral load is reported as normalized viral and is unitless.</description>
          <population>Phase 3: All randomized participants who received at least one dose of study drug and had a baseline and day 7 viral load value.</population>
          <units>unitless</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="403"/>
                <count group_id="O2" value="455"/>
                <count group_id="O3" value="614"/>
                <count group_id="O4" value="399"/>
                <count group_id="O5" value="122"/>
                <count group_id="O6" value="194"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.46" spread="0.095"/>
                    <measurement group_id="O2" value="-3.66" spread="0.090"/>
                    <measurement group_id="O3" value="-2.56" spread="0.079"/>
                    <measurement group_id="O4" value="-3.65" spread="0.098"/>
                    <measurement group_id="O5" value="-2.51" spread="0.185"/>
                    <measurement group_id="O6" value="-3.50" spread="0.147"/>
                  </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;0.0000000</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-1.20</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.46</ci_lower_limit>
            <ci_upper_limit>-0.94</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>&lt;0.0000000</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-1.09</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.34</ci_lower_limit>
            <ci_upper_limit>-0.85</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.00003777</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.45</ci_lower_limit>
            <ci_upper_limit>-0.52</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 3: Time to Sustained Symptom Resolution</title>
        <description>Sustained symptom resolution was defined as 2 consecutive assessments with a score of 0 for shortness of breath, feeling feverish, body aches and pains, sore throat, chills, and headache; and a score of 0 or 1 for cough and fatigue on the symptom questionnaire. Participants who did not experience sustained symptom resolution by completion or early discontinuation of study were censored at the date of their last visit during. Additionally, participants who were hospitalized were censored at their date of hospitalization.</description>
        <time_frame>Baseline through Day 29</time_frame>
        <population>Phase 3: All randomized participants (including censored) who received at least one dose of study drug and who had at least one post-baseline symptom measurement. Participants censored: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab = 121, 2800 mg Bamlanivimab + 2800 mg Etesevimab = 88, Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab= 226, 700 mg Bamlanivimab + 1400 mg Etesevimab= 128, Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab=44, 350 mg Bamlanivimab + 700 mg Etesevimab=43</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab</title>
            <description>Participants received Placebo administered intravenously (IV).</description>
          </group>
          <group group_id="O2">
            <title>Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab</title>
            <description>Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.</description>
          </group>
          <group group_id="O3">
            <title>Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab</title>
            <description>Participants received Placebo administered intravenously (IV).</description>
          </group>
          <group group_id="O4">
            <title>Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab</title>
            <description>Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.</description>
          </group>
          <group group_id="O5">
            <title>Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab</title>
            <description>Participants received Placebo administered intravenously (IV).</description>
          </group>
          <group group_id="O6">
            <title>Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab</title>
            <description>Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 3: Time to Sustained Symptom Resolution</title>
          <description>Sustained symptom resolution was defined as 2 consecutive assessments with a score of 0 for shortness of breath, feeling feverish, body aches and pains, sore throat, chills, and headache; and a score of 0 or 1 for cough and fatigue on the symptom questionnaire. Participants who did not experience sustained symptom resolution by completion or early discontinuation of study were censored at the date of their last visit during. Additionally, participants who were hospitalized were censored at their date of hospitalization.</description>
          <population>Phase 3: All randomized participants (including censored) who received at least one dose of study drug and who had at least one post-baseline symptom measurement. Participants censored: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab = 121, 2800 mg Bamlanivimab + 2800 mg Etesevimab = 88, Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab= 226, 700 mg Bamlanivimab + 1400 mg Etesevimab= 128, Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab=44, 350 mg Bamlanivimab + 700 mg Etesevimab=43</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="499"/>
                <count group_id="O2" value="508"/>
                <count group_id="O3" value="774"/>
                <count group_id="O4" value="510"/>
                <count group_id="O5" value="141"/>
                <count group_id="O6" value="213"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.00" lower_limit="8.00" upper_limit="10.00"/>
                    <measurement group_id="O2" value="8.00" lower_limit="7.00" upper_limit="8.00"/>
                    <measurement group_id="O3" value="9.00" lower_limit="9.00" upper_limit="10.00"/>
                    <measurement group_id="O4" value="8.00" lower_limit="7.00" upper_limit="9.00"/>
                    <measurement group_id="O5" value="9.00" lower_limit="8.00" upper_limit="13.00"/>
                    <measurement group_id="O6" value="6.00" lower_limit="5.00" upper_limit="8.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.007</p_value>
            <method>Stratified Log-rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.213</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </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>0.130</p_value>
            <method>Stratified Log-rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.111</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.012</p_value>
            <method>Stratified Log-rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.380</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 3: Time to SARS-CoV-2 Viral Clearance</title>
        <description>Participants who did not experience SARS-CoV-2 viral clearance by completion or early discontinuation of study were censored at the date of their last visit.</description>
        <time_frame>Baseline through Day 29</time_frame>
        <population>Phase 3: All randomized participants (Including censored) who received at least 1 dose of study drug and had at least 1 post-baseline viral load measurement. Censored participants: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab = 358, 2800 mg Bamlanivimab + 2800 mg Etesevimab = 325, Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab =530, 700 mg Bamlanivimab + 1400 mg Etesevimab= 326, Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab=95, 350 mg Bamlanivimab + 700 mg Etesevimab=114</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab</title>
            <description>Participants received Placebo administered intravenously (IV).</description>
          </group>
          <group group_id="O2">
            <title>Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab</title>
            <description>Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.</description>
          </group>
          <group group_id="O3">
            <title>Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab</title>
            <description>Participants received Placebo administered intravenously (IV).</description>
          </group>
          <group group_id="O4">
            <title>Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab</title>
            <description>Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.</description>
          </group>
          <group group_id="O5">
            <title>Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab</title>
            <description>Participants received Placebo administered intravenously (IV).</description>
          </group>
          <group group_id="O6">
            <title>Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab</title>
            <description>Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 3: Time to SARS-CoV-2 Viral Clearance</title>
          <description>Participants who did not experience SARS-CoV-2 viral clearance by completion or early discontinuation of study were censored at the date of their last visit.</description>
          <population>Phase 3: All randomized participants (Including censored) who received at least 1 dose of study drug and had at least 1 post-baseline viral load measurement. Censored participants: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab = 358, 2800 mg Bamlanivimab + 2800 mg Etesevimab = 325, Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab =530, 700 mg Bamlanivimab + 1400 mg Etesevimab= 326, Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab=95, 350 mg Bamlanivimab + 700 mg Etesevimab=114</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="499"/>
                <count group_id="O2" value="508"/>
                <count group_id="O3" value="774"/>
                <count group_id="O4" value="510"/>
                <count group_id="O5" value="141"/>
                <count group_id="O6" value="213"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Median cannot be calculated due to insufficient number of events occurring within the timeframe.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Median cannot be calculated due to insufficient number of events occurring within the timeframe.</measurement>
                    <measurement group_id="O3" value="NA" lower_limit="NA" upper_limit="NA">Median cannot be calculated due to insufficient number of events occurring within the timeframe.</measurement>
                    <measurement group_id="O4" value="NA" lower_limit="NA" upper_limit="NA">Median cannot be calculated due to insufficient number of events occurring within the timeframe.</measurement>
                    <measurement group_id="O5" value="NA" lower_limit="NA" upper_limit="NA">Median cannot be calculated due to insufficient number of events occurring within the timeframe.</measurement>
                    <measurement group_id="O6" value="NA" lower_limit="14.00" upper_limit="NA">Median cannot be calculated due to insufficient number of events occurring within the timeframe.</measurement>
                  </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>0.007</p_value>
            <method>Stratified Log-rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.355</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.033</p_value>
            <method>Stratified Log-rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.237</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.017</p_value>
            <method>Stratified Log-rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.521</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 2: Change From Baseline to Day 11 in SARS-CoV-2 Viral Load Among Participants Enrolled With Recent Symptoms Prior to Randomization</title>
        <description>SARS-CoV-2 viral load was based on nasopharyngeal swab sampling for reverse transcription polymerase chain reaction (RT-PCR) testing for SARS-CoV-2. This analysis included only participants whose symptoms developed no more than 8 days prior to randomization. Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. If Day 11 SARS-CoV-2 viral load is missing, the earliest measurement closest to the Day 11 visit, but within 4 days (Day 7-Day 15), will be used for the Day 11 value. If no measurements are available, the Day 11 viral load will be treated as MAR in the analysis.</description>
        <time_frame>Baseline, Day 11</time_frame>
        <population>Phase 2: All randomized participants who received at least one dose of study drug and had baseline and post-baseline viral load value. Participants enrolled with recent symptoms prior to randomization.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 2: Placebo</title>
            <description>Participants received Placebo administered intravenously (IV).</description>
          </group>
          <group group_id="O2">
            <title>Phase 2: 700 mg Bamlanivimab</title>
            <description>Participants received 700 mg bamlanivimab administered IV.</description>
          </group>
          <group group_id="O3">
            <title>Phase 2: 2800 mg Bamlanivimab</title>
            <description>Participants received 2800 mg bamlanivimab administered IV.</description>
          </group>
          <group group_id="O4">
            <title>Phase 2: 7000 mg Bamlanivimab</title>
            <description>Participants received 7000 mg bamlanivimab administered IV.</description>
          </group>
          <group group_id="O5">
            <title>Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab</title>
            <description>Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 2: Change From Baseline to Day 11 in SARS-CoV-2 Viral Load Among Participants Enrolled With Recent Symptoms Prior to Randomization</title>
          <description>SARS-CoV-2 viral load was based on nasopharyngeal swab sampling for reverse transcription polymerase chain reaction (RT-PCR) testing for SARS-CoV-2. This analysis included only participants whose symptoms developed no more than 8 days prior to randomization. Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. If Day 11 SARS-CoV-2 viral load is missing, the earliest measurement closest to the Day 11 visit, but within 4 days (Day 7-Day 15), will be used for the Day 11 value. If no measurements are available, the Day 11 viral load will be treated as MAR in the analysis.</description>
          <population>Phase 2: All randomized participants who received at least one dose of study drug and had baseline and post-baseline viral load value. Participants enrolled with recent symptoms prior to randomization.</population>
          <units>unitless</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="123"/>
                <count group_id="O2" value="84"/>
                <count group_id="O3" value="88"/>
                <count group_id="O4" value="81"/>
                <count group_id="O5" value="95"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.03" spread="0.155"/>
                    <measurement group_id="O2" value="-3.87" spread="0.187"/>
                    <measurement group_id="O3" value="-4.20" spread="0.184"/>
                    <measurement group_id="O4" value="-3.65" spread="0.191"/>
                    <measurement group_id="O5" value="-4.46" spread="0.178"/>
                  </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>0.499</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.16</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.243</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.31</ci_lower_limit>
            <ci_upper_limit>0.64</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.492</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.17</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.241</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.64</ci_lower_limit>
            <ci_upper_limit>0.31</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.125</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.38</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.246</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.11</ci_lower_limit>
            <ci_upper_limit>0.86</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.069</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.43</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.236</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.89</ci_lower_limit>
            <ci_upper_limit>0.03</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 2: Percentage of Participants Demonstrating Symptom Resolution</title>
        <description>Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and changes in taste and smell. Each symptom will be scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Symptom resolution was defined as all symptoms (those scored 0-3) on the symptom questionnaire scored as absent (0). Symptom Resolution (yes/no) was defined as all symptoms (excluding the loss of appetite and changes in taste and smell symptoms) on the symptom questionnaire scored as absent vs otherwise.&#xD;
Missing data were imputed using non-responder imputation (NRI) method.</description>
        <time_frame>Day 11</time_frame>
        <population>Phase 2: All randomized participants who received at least one dose of study drug and had non-missing Symptom Resolution values</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 2: Placebo</title>
            <description>Participants received Placebo administered intravenously (IV).</description>
          </group>
          <group group_id="O2">
            <title>Phase 2: 700 mg Bamlanivimab</title>
            <description>Participants received 700 mg bamlanivimab administered IV.</description>
          </group>
          <group group_id="O3">
            <title>Phase 2: 2800 mg Bamlanivimab</title>
            <description>Participants received 2800 mg bamlanivimab administered IV.</description>
          </group>
          <group group_id="O4">
            <title>Phase 2: 7000 mg Bamlanivimab</title>
            <description>Participants received 7000 mg bamlanivimab administered IV.</description>
          </group>
          <group group_id="O5">
            <title>Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab</title>
            <description>Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 2: Percentage of Participants Demonstrating Symptom Resolution</title>
          <description>Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and changes in taste and smell. Each symptom will be scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Symptom resolution was defined as all symptoms (those scored 0-3) on the symptom questionnaire scored as absent (0). Symptom Resolution (yes/no) was defined as all symptoms (excluding the loss of appetite and changes in taste and smell symptoms) on the symptom questionnaire scored as absent vs otherwise.&#xD;
Missing data were imputed using non-responder imputation (NRI) method.</description>
          <population>Phase 2: All randomized participants who received at least one dose of study drug and had non-missing Symptom Resolution values</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="152"/>
                <count group_id="O2" value="101"/>
                <count group_id="O3" value="107"/>
                <count group_id="O4" value="101"/>
                <count group_id="O5" value="109"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.8" lower_limit="29.2" upper_limit="44.5"/>
                    <measurement group_id="O2" value="50.5" lower_limit="40.7" upper_limit="60.2"/>
                    <measurement group_id="O3" value="40.2" lower_limit="30.9" upper_limit="49.5"/>
                    <measurement group_id="O4" value="43.6" lower_limit="33.9" upper_limit="53.2"/>
                    <measurement group_id="O5" value="45.9" lower_limit="36.5" upper_limit="55.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.034</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.74</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.04</ci_lower_limit>
            <ci_upper_limit>2.90</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.594</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.15</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.69</ci_lower_limit>
            <ci_upper_limit>1.91</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.291</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.32</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.79</ci_lower_limit>
            <ci_upper_limit>2.20</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.143</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.45</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.88</ci_lower_limit>
            <ci_upper_limit>2.40</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 2: Percentage of Participants Demonstrating Symptom Improvement</title>
        <description>Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and changes in taste and smell. Each symptom will be scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Symptom improvement was defined as a participant experiencing both: Symptoms on the symptom questionnaire scored as moderate or severe at baseline are subsequently scored as mild or absent, and Symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent. Missing data were imputed using NRI method.</description>
        <time_frame>Day 11</time_frame>
        <population>Phase 2: All randomized participants who received at least one dose of study drug and had non-missing Symptom Improvement values</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 2: Placebo</title>
            <description>Participants received Placebo administered intravenously (IV).</description>
          </group>
          <group group_id="O2">
            <title>Phase 2: 700 mg Bamlanivimab</title>
            <description>Participants received 700 mg bamlanivimab administered IV.</description>
          </group>
          <group group_id="O3">
            <title>Phase 2: 2800 mg Bamlanivimab</title>
            <description>Participants received 2800 mg bamlanivimab administered IV.</description>
          </group>
          <group group_id="O4">
            <title>Phase 2: 7000 mg Bamlanivimab</title>
            <description>Participants received 7000 mg bamlanivimab administered IV.</description>
          </group>
          <group group_id="O5">
            <title>Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab</title>
            <description>Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV..</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 2: Percentage of Participants Demonstrating Symptom Improvement</title>
          <description>Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and changes in taste and smell. Each symptom will be scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Symptom improvement was defined as a participant experiencing both: Symptoms on the symptom questionnaire scored as moderate or severe at baseline are subsequently scored as mild or absent, and Symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent. Missing data were imputed using NRI method.</description>
          <population>Phase 2: All randomized participants who received at least one dose of study drug and had non-missing Symptom Improvement values</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="152"/>
                <count group_id="O2" value="101"/>
                <count group_id="O3" value="107"/>
                <count group_id="O4" value="101"/>
                <count group_id="O5" value="109"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.4" lower_limit="35.5" upper_limit="51.3"/>
                    <measurement group_id="O2" value="59.4" lower_limit="49.8" upper_limit="69.0"/>
                    <measurement group_id="O3" value="44.9" lower_limit="35.4" upper_limit="54.3"/>
                    <measurement group_id="O4" value="58.4" lower_limit="48.8" upper_limit="68.0"/>
                    <measurement group_id="O5" value="53.2" lower_limit="43.8" upper_limit="62.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.014</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.89</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.14</ci_lower_limit>
            <ci_upper_limit>3.15</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.828</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.06</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.64</ci_lower_limit>
            <ci_upper_limit>1.74</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.022</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.82</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.09</ci_lower_limit>
            <ci_upper_limit>3.02</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.119</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.48</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.90</ci_lower_limit>
            <ci_upper_limit>2.43</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 2, Pharmacokinetics (PK): Mean Concentration of Bamlanivimab Alone and in the Presence of Etesevimab</title>
        <description>(PK): Mean Concentration of Bamlanivimab alone and in the Presence of Etesevimab</description>
        <time_frame>Day 29 Post-dose</time_frame>
        <population>Phase 2: All randomized participants who received a complete dose of Bamlanivimab (for Bamlanivimab only arms) or Bamlanivimab in the Presence of Etesevimab (for Bamlanivimab + Etesevimab) and had at least 1 post-dose PK sample.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 2: 700 mg Bamlanivimab</title>
            <description>Participants received 700 mg bamlanivimab (alone) administered IV.</description>
          </group>
          <group group_id="O2">
            <title>Phase 2: 2800 mg Bamlanivimab</title>
            <description>Participants received 2800 mg bamlanivimab (alone) administered IV.</description>
          </group>
          <group group_id="O3">
            <title>Phase 2: 7000 mg Bamlanivimab</title>
            <description>Participants received 7000 mg bamlanivimab (alone) administered IV..</description>
          </group>
          <group group_id="O4">
            <title>Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab</title>
            <description>Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 2, Pharmacokinetics (PK): Mean Concentration of Bamlanivimab Alone and in the Presence of Etesevimab</title>
          <description>(PK): Mean Concentration of Bamlanivimab alone and in the Presence of Etesevimab</description>
          <population>Phase 2: All randomized participants who received a complete dose of Bamlanivimab (for Bamlanivimab only arms) or Bamlanivimab in the Presence of Etesevimab (for Bamlanivimab + Etesevimab) and had at least 1 post-dose PK sample.</population>
          <units>Microgram/milliliter (µg/mL)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="80"/>
                <count group_id="O2" value="89"/>
                <count group_id="O3" value="86"/>
                <count group_id="O4" value="92"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.6" spread="42.2"/>
                    <measurement group_id="O2" value="83.8" spread="50.0"/>
                    <measurement group_id="O3" value="227" spread="39.6"/>
                    <measurement group_id="O4" value="100" spread="46.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 2, PK: Mean Concentration of Etesevimab in the Presence of Bamlanivimab</title>
        <description>PK: Mean Concentration of Etesevimab in the Presence of Bamlanivimab</description>
        <time_frame>Day 29 Post-dose</time_frame>
        <population>Phase 2: All randomized participants who received a complete dose of Etesevimab in the Presence of Bamlanivimab and had at least 1 post-dose PK sample.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab</title>
            <description>Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 2, PK: Mean Concentration of Etesevimab in the Presence of Bamlanivimab</title>
          <description>PK: Mean Concentration of Etesevimab in the Presence of Bamlanivimab</description>
          <population>Phase 2: All randomized participants who received a complete dose of Etesevimab in the Presence of Bamlanivimab and had at least 1 post-dose PK sample.</population>
          <units>µg/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="243" spread="35.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 2: Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause</title>
        <description>Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related ER Visit, or Death from Any Cause</description>
        <time_frame>Baseline through Day 85</time_frame>
        <population>Phase 2: All participants who received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: Placebo</title>
            <description>Participants received Placebo administered intravenously (IV).</description>
          </group>
          <group group_id="O2">
            <title>Phase 2: 700 mg Bamlanivimab</title>
            <description>Participants received 700 mg bamlanivimab administered IV.</description>
          </group>
          <group group_id="O3">
            <title>Phase 2: 2800 mg Bamlanivimab</title>
            <description>Participants received 2800 mg bamlanivimab administered IV.</description>
          </group>
          <group group_id="O4">
            <title>Phase 2: 7000 mg Bamlanivimab</title>
            <description>Participants received 7000 mg bamlanivimab administered IV.</description>
          </group>
          <group group_id="O5">
            <title>Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab</title>
            <description>Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 2: Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause</title>
          <description>Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related ER Visit, or Death from Any Cause</description>
          <population>Phase 2: All participants who received at least one dose of study drug.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="156"/>
                <count group_id="O2" value="101"/>
                <count group_id="O3" value="107"/>
                <count group_id="O4" value="101"/>
                <count group_id="O5" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.8" lower_limit="2.1" upper_limit="9.4"/>
                    <measurement group_id="O2" value="1.0" lower_limit="0.0" upper_limit="2.9"/>
                    <measurement group_id="O3" value="1.9" lower_limit="0.0" upper_limit="4.4"/>
                    <measurement group_id="O4" value="2.0" lower_limit="0.0" upper_limit="4.7"/>
                    <measurement group_id="O5" value="0.9" lower_limit="0.0" upper_limit="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.098</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.23</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.04</ci_lower_limit>
            <ci_upper_limit>1.31</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.165</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.37</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.09</ci_lower_limit>
            <ci_upper_limit>1.51</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.191</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.39</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.10</ci_lower_limit>
            <ci_upper_limit>1.60</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.075</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.21</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.04</ci_lower_limit>
            <ci_upper_limit>1.18</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 2: Time to SARS-CoV-2 Viral Clearance</title>
        <description>Participants who did not experience SARS-CoV-2 viral clearance by completion or early discontinuation of study were censored at the date of their last visit.</description>
        <time_frame>Baseline through Day 29</time_frame>
        <population>Phase 2: All randomized participants (including censored) who received at least one dose of study drug and had at least one post-baseline viral load measurement. Censored: Part A: Placebo= 68, Phase 2: 700 mg Bamlanivimab=39, Phase 2: 2800 mg Bamlanivimab=40, Phase 2: 7000 mg Bamlanivimab=42 and Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab=45</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 2: Placebo</title>
            <description>Participants received Placebo administered intravenously (IV).</description>
          </group>
          <group group_id="O2">
            <title>Phase 2: 700 mg Bamlanivimab</title>
            <description>Participants received 700 mg bamlanivimab administered IV.</description>
          </group>
          <group group_id="O3">
            <title>Phase 2: 2800 mg Bamlanivimab</title>
            <description>Participants received 2800 mg bamlanivimab administered IV.</description>
          </group>
          <group group_id="O4">
            <title>Phase 2: 7000 mg Bamlanivimab</title>
            <description>Participants received 7000 mg bamlanivimab administered IV..</description>
          </group>
          <group group_id="O5">
            <title>Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab</title>
            <description>Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV..</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 2: Time to SARS-CoV-2 Viral Clearance</title>
          <description>Participants who did not experience SARS-CoV-2 viral clearance by completion or early discontinuation of study were censored at the date of their last visit.</description>
          <population>Phase 2: All randomized participants (including censored) who received at least one dose of study drug and had at least one post-baseline viral load measurement. Censored: Part A: Placebo= 68, Phase 2: 700 mg Bamlanivimab=39, Phase 2: 2800 mg Bamlanivimab=40, Phase 2: 7000 mg Bamlanivimab=42 and Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab=45</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="152"/>
                <count group_id="O2" value="101"/>
                <count group_id="O3" value="107"/>
                <count group_id="O4" value="101"/>
                <count group_id="O5" value="109"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24" lower_limit="22.00" upper_limit="NA">Some upper bound confidence intervals were not estimable due to insufficient events occurring within the timeframe.</measurement>
                    <measurement group_id="O2" value="25.00" lower_limit="21.00" upper_limit="27.00"/>
                    <measurement group_id="O3" value="23.00" lower_limit="19.00" upper_limit="25.00"/>
                    <measurement group_id="O4" value="25.00" lower_limit="22.00" upper_limit="NA">Some upper bound confidence intervals were not estimable due to insufficient events occurring within the timeframe.</measurement>
                    <measurement group_id="O5" value="21.00" lower_limit="17.00" upper_limit="NA">Some upper bound confidence intervals were not estimable due to insufficient events occurring within the timeframe.</measurement>
                  </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>0.616</p_value>
            <method>Stratified Log-rank</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.281</p_value>
            <method>Stratified Log-rank</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.815</p_value>
            <method>Stratified Log-rank</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.334</p_value>
            <method>Stratified Log-rank</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline Up To 85 Days</time_frame>
      <desc>All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.</desc>
      <group_list>
        <group group_id="E1">
          <title>Phase 2: Placebo</title>
          <description>Participants received Placebo administered intravenously (IV).</description>
        </group>
        <group group_id="E2">
          <title>Phase 2: 700 mg Bamlanivimab</title>
          <description>Participants received 700 mg bamlanivimab administered IV.</description>
        </group>
        <group group_id="E3">
          <title>Phase 2: 2800 mg Bamlanivimab</title>
          <description>Participants received 2800 mg bamlanivimab administered IV.</description>
        </group>
        <group group_id="E4">
          <title>Phase 2: 7000 mg Bamlanivimab</title>
          <description>Participants received 7000 mg bamlanivimab administered IV.</description>
        </group>
        <group group_id="E5">
          <title>Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab</title>
          <description>Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.</description>
        </group>
        <group group_id="E6">
          <title>Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab</title>
          <description>Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.</description>
        </group>
        <group group_id="E7">
          <title>Phase 3: Placebo</title>
          <description>Participants received Placebo administered intravenously (IV).</description>
        </group>
        <group group_id="E8">
          <title>Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab</title>
          <description>Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.</description>
        </group>
        <group group_id="E9">
          <title>Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab</title>
          <description>Participants received Placebo administered intravenously (IV).</description>
        </group>
        <group group_id="E10">
          <title>Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab</title>
          <description>Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.</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="0" subjects_at_risk="156"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" subjects_affected="15" subjects_at_risk="776"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="101"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E6" subjects_affected="10" subjects_at_risk="518"/>
                <counts group_id="E7" subjects_affected="8" subjects_at_risk="776"/>
                <counts group_id="E8" subjects_affected="16" subjects_at_risk="513"/>
                <counts group_id="E9" subjects_affected="4" subjects_at_risk="141"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="2" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Ventricular extrasystoles</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Macular oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Retinal vein occlusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Duodenitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Intussusception</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Sudden death</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Covid-19 pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Localised infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Medical device site joint infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Perirectal abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Sialoadenitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Bone contusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Concussion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Foot fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Toxicity to various agents</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Catheterisation cardiac</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Diabetic ketoacidosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Clear cell renal cell carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Lung neoplasm malignant</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </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="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Heavy menstrual bleeding</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="279"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Uterine mass</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="279"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Respiratory arrest</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Arterial occlusive disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="44" subjects_at_risk="156"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="101"/>
                <counts group_id="E3" subjects_affected="26" subjects_at_risk="107"/>
                <counts group_id="E4" subjects_affected="24" subjects_at_risk="101"/>
                <counts group_id="E5" subjects_affected="23" subjects_at_risk="112"/>
                <counts group_id="E6" subjects_affected="72" subjects_at_risk="518"/>
                <counts group_id="E7" subjects_affected="92" subjects_at_risk="776"/>
                <counts group_id="E8" subjects_affected="61" subjects_at_risk="513"/>
                <counts group_id="E9" subjects_affected="17" subjects_at_risk="141"/>
                <counts group_id="E10" subjects_affected="14" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="4" subjects_affected="4" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="2" subjects_affected="2" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Microcytic anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Monocytopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Thrombocytosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Ventricular extrasystoles</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Ventricular tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Blepharitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Blepharospasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Cataract nuclear</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Diplopia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Eye pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Eye paraesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Eyelids pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Photophobia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Retinal vein occlusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Retinopathy hypertensive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Visual impairment</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Vitreous haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Xanthopsia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="107"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Aphthous ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="156"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="107"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="101"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="518"/>
                <counts group_id="E7" events="3" subjects_affected="3" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Frequent bowel movements</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Gastric ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Gastritis haemorrhagic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Gastrointestinal motility disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="112"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Haematemesis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Haemorrhoids thrombosed</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Hiatus hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia oral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Irritable bowel syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Melaena</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Mouth ulceration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="156"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="101"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="107"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="101"/>
                <counts group_id="E5" events="5" subjects_affected="4" subjects_at_risk="112"/>
                <counts group_id="E6" events="5" subjects_affected="5" subjects_at_risk="518"/>
                <counts group_id="E7" events="5" subjects_affected="5" subjects_at_risk="776"/>
                <counts group_id="E8" events="4" subjects_affected="3" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Oesophageal ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Oral disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Paraesthesia oral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Retching</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Swollen tongue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Tongue ulceration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="156"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="107"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="107"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="107"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Extravasation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="107"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Feeling abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Infusion site pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Infusion site rash</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Injection site extravasation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Nodule</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="107"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Swelling face</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Thirst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Xerosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Drug hypersensitivity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Candida infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Covid-19</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Epididymitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="239"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="372"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="105"/>
              </event>
              <event>
                <sub_title>Eye infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Fungal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Gangrene</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Herpes simplex</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Herpes virus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Localised infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Onychomycosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Pelvic inflammatory disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="85"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="279"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Pilonidal cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Pneumonia bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Pneumonia viral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Tooth abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Tooth infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="101"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="518"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="3" subjects_affected="3" subjects_at_risk="141"/>
                <counts group_id="E10" events="2" subjects_affected="2" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Vaginal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="279"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Vulvovaginal mycotic infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="279"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Animal bite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Arthropod bite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Arthropod sting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Concussion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Exposure during pregnancy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Facial bones fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="513"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Joint injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Ligament rupture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Lower limb fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Maternal exposure during pregnancy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="279"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Nail avulsion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Skin abrasion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Skin laceration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Tibia fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Upper limb fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Vaccination complication</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Amylase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Blood bicarbonate decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Blood glucose increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Blood lactate dehydrogenase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Blood phosphorus decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Blood urea increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Blood uric acid increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Blood urine</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>C-reactive protein increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="513"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Electrocardiogram t wave abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Eosinophil count increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Epstein-barr virus antibody positive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Fibrin d dimer increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Heart rate irregular</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Liver function test increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="3" subjects_affected="3" subjects_at_risk="776"/>
                <counts group_id="E8" events="3" subjects_affected="3" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Lymphocyte morphology abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Neutrophil count increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Occult blood positive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Platelet count increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Serum ferritin increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Acidosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Diabetic ketoacidosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Glucose tolerance impaired</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="776"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Hypercholesterolaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Hyperlipidaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Hypovolaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Iron deficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Malnutrition</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Type 2 diabetes mellitus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="513"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Vitamin b12 deficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Vitamin d deficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="776"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="513"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="776"/>
                <counts group_id="E8" events="4" subjects_affected="4" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Coccydynia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Extremity contracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Fibromyalgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Joint contracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Joint swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="776"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Muscle twitching</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Musculoskeletal stiffness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Pain in jaw</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Periarthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Rheumatoid arthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Rotator cuff syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Spinal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Lipoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Balance disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Burning sensation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="156"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="101"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="107"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="101"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E6" events="4" subjects_affected="4" subjects_at_risk="518"/>
                <counts group_id="E7" events="4" subjects_affected="3" subjects_at_risk="776"/>
                <counts group_id="E8" events="5" subjects_affected="4" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="156"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="101"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="156"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Hyporeflexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Incoherent</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Loss of consciousness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Mental impairment</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Nerve compression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Parkinson's disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Restless legs syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="107"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Pregnancy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="279"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="3" subjects_affected="3" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Bipolar disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Hallucination, auditory</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="107"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Panic attack</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Restlessness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Chromaturia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="776"/>
                <counts group_id="E8" events="3" subjects_affected="3" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Renal cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Renal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Urinary incontinence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Benign prostatic hyperplasia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="239"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="372"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="248"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="105"/>
              </event>
              <event>
                <sub_title>Menstruation delayed</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="279"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="404"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Menstruation irregular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="279"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Vulva cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="279"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Atelectasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Oropharyngeal discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Paranasal sinus discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Pharyngeal swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Pleurisy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Rhinalgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="3" subjects_affected="3" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Sinus congestion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Throat irritation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Upper-airway cough syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Cold sweat</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Ingrowing nail</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Night sweats</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="101"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="112"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="3" subjects_affected="3" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E6" events="6" subjects_affected="6" subjects_at_risk="518"/>
                <counts group_id="E7" events="6" subjects_affected="6" subjects_at_risk="776"/>
                <counts group_id="E8" events="3" subjects_affected="3" subjects_at_risk="513"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Rash pruritic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Rosacea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Skin disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Social circumstances</title>
            <event_list>
              <event>
                <sub_title>Bereavement</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Abortion induced</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="279"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="404"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Appendicectomy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Thrombectomy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Arteriosclerosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Dialysis hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="518"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="141"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Peripheral artery occlusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </event>
              <event>
                <sub_title>Phlebitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="107"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="518"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="776"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="513"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="141"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="213"/>
              </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 only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Chief Medical Officer</name_or_title>
      <organization>Eli Lilly and Company</organization>
      <phone>800-545-5979</phone>
      <email>ClinicalTrials.gov@lilly.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/NCT04427501
org study id: 17947
secondary id: J2W-MC-PYAB
nct id: NCT04427501
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The purpose of this study is to measure how well LY3819253 and LY3832479 work against the
      virus that causes COVID-19. LY3819253 and LY3832479 will be given to participants with early
      symptoms of COVID-19. Samples will be taken from the back of the nose to determine how much
      virus is in the body at various times during the study. Participation could last about 12
      weeks and includes one required visit to the study site, with the remainder of assessments
      performed in the home or by phone.

      Pediatric participants, with mild to moderate COVID-19 illness, will enroll in a single-arm
      (Arm 23), open-label addendum to evaluate the pharmacokinetics and safety of LY3853113.
      Enrollment began on August 19, 2022 and completed on February 21, 2023.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: Some treatment arms are open label.
measure: Phase 3: Percentage of Participants Who Experience COVID-Related Hospitalization or Death From Any Cause in 2800 mg Bamlanivumab/2800 mg Etesevimab, 700 mg Bamlanivimab/1400mg Etesevimab and Their Placebo Groups
time frame: Baseline through Day 29
description: COVID-19 Related Deterioration (yes/no) was defined as a participant experiencing COVID-19-related hospitalization (defined as 24 hours of acute care) or death from any cause by Day 29.
measure: Phase 3: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than a Prespecified Threshold in Arms 350 mg Bamlanivimab/700 mg Etesevimab and Placebo
time frame: Day 7
description: SARS-CoV-2 persistent high viral load (yes/no) was defined as ribonuclease P(RP) normalized viral load >=5.27 vs otherwise.
measure: Phase 2: Change From Baseline to Day 11 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load
time frame: Baseline, Day 11
description: SARS-CoV-2 viral load was based on nasopharyngeal swab sampling for reverse transcription polymerase chain reaction (RT-PCR) testing for SARS-CoV-2. Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. If Day 11 SARS-CoV-2 viral load was missing, the earliest measurement closest to the Day 11 visit, but within 4 days (Day 7-Day 15), was used for the Day 11 value. If no measurements were available, the Day 11 viral load was treated as missing at random (MAR) in the analysis.
Viral load is reported as normalized viral load and is unitless.
measure: Phase 2: Percentage of Participants Who Experience a Serious Adverse Event(s) SAE(s)
time frame: Baseline through Day 85
description: An SAE was defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect and other different situations will have medical or scientific judgment to determine if they are SAE. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality are reported in the Adverse Events section.
measure: Phase 3: Percentage of Participants Demonstrating Symptom Resolution
time frame: Day 11
description: Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and changes in taste and smell. Each symptom was scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Symptom resolution (yes/no) is defined as a score of 0 for shortness of breath, feeling feverish, body aches and pains, sore throat, chills, and headache; and a score of 0 or 1 for cough and fatigue on the symptom questionnaire (excluding the loss of appetite and changes in taste and smell symptoms). Missing data were imputed using non-responder imputation (NRI) method.
measure: Phase 3: Percentage of Participants Demonstrating Symptom Improvement
time frame: Day 11
description: Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and changes in taste and smell. Each symptom will be scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Symptom improvement was defined as a participant experiencing both: Symptoms on the symptom questionnaire scored as moderate or severe at baseline are subsequently scored as mild or absent, and symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent. Missing data were imputed using NRI method.
measure: Phase 3: Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause
time frame: Baseline through Day 85
description: COVID-19 Related Deterioration (yes/no) is defined as a patient experiencing COVID-19-related hospitalization, Emergency Room Visit, or Death from any causes vs otherwise.
measure: Phase 3: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
time frame: Baseline, Day 7
description: Change from baseline to Day 7 (±2 days) in SARS-CoV-2 viral load was based on nasopharyngeal swab sampling for reverse transcription polymerase chain reaction (RT-PCR) testing for SARS-CoV-2. Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. If Day 7 SARS-CoV-2 viral load was missing, the earliest measurement closest to the Day 7 visit, but within 2 days (Day 5-Day 9), was used for the Day 7 value. If no measurements are available, the Day 7 viral load was treated as missing at random (MAR) in the analysis.
Viral load is reported as normalized viral and is unitless.
measure: Phase 3: Time to Sustained Symptom Resolution
time frame: Baseline through Day 29
description: Sustained symptom resolution was defined as 2 consecutive assessments with a score of 0 for shortness of breath, feeling feverish, body aches and pains, sore throat, chills, and headache; and a score of 0 or 1 for cough and fatigue on the symptom questionnaire. Participants who did not experience sustained symptom resolution by completion or early discontinuation of study were censored at the date of their last visit during. Additionally, participants who were hospitalized were censored at their date of hospitalization.
measure: Phase 3: Time to SARS-CoV-2 Viral Clearance
time frame: Baseline through Day 29
description: Participants who did not experience SARS-CoV-2 viral clearance by completion or early discontinuation of study were censored at the date of their last visit.
measure: Phase 2: Change From Baseline to Day 11 in SARS-CoV-2 Viral Load Among Participants Enrolled With Recent Symptoms Prior to Randomization
time frame: Baseline, Day 11
description: SARS-CoV-2 viral load was based on nasopharyngeal swab sampling for reverse transcription polymerase chain reaction (RT-PCR) testing for SARS-CoV-2. This analysis included only participants whose symptoms developed no more than 8 days prior to randomization. Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. If Day 11 SARS-CoV-2 viral load is missing, the earliest measurement closest to the Day 11 visit, but within 4 days (Day 7-Day 15), will be used for the Day 11 value. If no measurements are available, the Day 11 viral load will be treated as MAR in the analysis.
measure: Phase 2: Percentage of Participants Demonstrating Symptom Resolution
time frame: Day 11
description: Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and changes in taste and smell. Each symptom will be scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Symptom resolution was defined as all symptoms (those scored 0-3) on the symptom questionnaire scored as absent (0). Symptom Resolution (yes/no) was defined as all symptoms (excluding the loss of appetite and changes in taste and smell symptoms) on the symptom questionnaire scored as absent vs otherwise.
Missing data were imputed using non-responder imputation (NRI) method.
measure: Phase 2: Percentage of Participants Demonstrating Symptom Improvement
time frame: Day 11
description: Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and changes in taste and smell. Each symptom will be scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Symptom improvement was defined as a participant experiencing both: Symptoms on the symptom questionnaire scored as moderate or severe at baseline are subsequently scored as mild or absent, and Symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent. Missing data were imputed using NRI method.
measure: Phase 2, Pharmacokinetics (PK): Mean Concentration of Bamlanivimab Alone and in the Presence of Etesevimab
time frame: Day 29 Post-dose
description: (PK): Mean Concentration of Bamlanivimab alone and in the Presence of Etesevimab
measure: Phase 2, PK: Mean Concentration of Etesevimab in the Presence of Bamlanivimab
time frame: Day 29 Post-dose
description: PK: Mean Concentration of Etesevimab in the Presence of Bamlanivimab
measure: Phase 2: Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause
time frame: Baseline through Day 85
description: Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related ER Visit, or Death from Any Cause
measure: Phase 2: Time to SARS-CoV-2 Viral Clearance
time frame: Baseline through Day 29
description: Participants who did not experience SARS-CoV-2 viral clearance by completion or early discontinuation of study were censored at the date of their last visit.
arm group label: LY3819253
arm group type: Experimental
description: 700 mg, 2800 mg, 7000 mg, LY3819253 administered intravenously (IV)
arm group label: LY3819253 + LY3832479
arm group type: Experimental
description: 350 mg, 700 mg, 2800 mg LY3819253 + 700 mg, 1400 mg, 2800 mg LY3832479 administered IV or subcutaneously (SQ)
arm group label: LY3853113 Open Label Addenda Arm 23
arm group type: Experimental
description: Administered IV
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo administered IV
intervention type: Drug
intervention name: LY3819253
description: Administered IV
arm group label: LY3819253
arm group label: LY3819253 + LY3832479
other name: LY-CoV555
other name: Bamlanivimab
intervention type: Drug
intervention name: LY3832479
description: Administered IV
arm group label: LY3819253 + LY3832479
other name: LY-CoV016
other name: Etesevimab
intervention type: Drug
intervention name: LY3853113
description: Administered IV
arm group label: LY3853113 Open Label Addenda Arm 23
other name: bebtelovimab
intervention type: Drug
intervention name: Placebo
description: Administered IV
arm group label: Placebo
criteria: 
gender: All
minimum age: 0 Years
maximum age: N/A
healthy volunteers: No
last name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: Study Director
affiliation: Eli Lilly and Company
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country: United States
country: Puerto Rico
url: https://trials.lillytrialguide.com/en-US/trial/63aASRmBPQCBCOfy5oO0er
description: A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Participants With Mild to Moderate COVID-19 Illness (BLAZE-1)
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Bamlanivimab
sharing ipd: Yes
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting
ipd access criteria: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting
ipd url: http://vivli.org/
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point of contact: 