<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/NCT03013543</url>
  </required_header>
  <id_info>
    <org_study_id>RM-493-014</org_study_id>
    <secondary_id>2017-000387-14</secondary_id>
    <nct_id>NCT03013543</nct_id>
  </id_info>
  <brief_title>Setmelanotide Phase 2 Treatment Trial in Participants With Rare Genetic Disorders of Obesity</brief_title>
  <official_title>Setmelanotide (RM-493) Phase 2 Treatment Trial in Patients With Rare Genetic Disorders of Obesity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rhythm Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rhythm Pharmaceuticals, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study was to determine the effect of setmelanotide (RM-493) on weight,&#xD;
      hunger assessments, and other factors in participants with rare genetic disorders of obesity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 10, 2017</start_date>
  <completion_date type="Actual">March 1, 2022</completion_date>
  <primary_completion_date type="Actual">March 1, 2022</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With ≥ 5% Reduction in Body Weight From Baseline After 3 Months of Setmelanotide Treatment</measure>
    <time_frame>Baseline to Month 3</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment-Emergent Adverse Events (TEAEs)</measure>
    <time_frame>From first dose up to Month 16</time_frame>
    <description>An adverse event (AE) was any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE (also referred to as an adverse experience) could be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality. TEAEs were defined as AEs reported after dosing on Day 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Body Weight After 3 Months of Setmelanotide Treatment</measure>
    <time_frame>Baseline, Month 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Body Weight After 3 Months of Setmelanotide Treatment</measure>
    <time_frame>Baseline, Month 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years</measure>
    <time_frame>Baseline, Month 3</time_frame>
    <description>The mean change in daily hunger questionnaire scores for participants ≥ 12 years of age with obesity in treatment with setmelanotide was evaluated. On the Daily Hunger Questionnaire, each of the 3 items (average hunger in the last 24 hours, most/worst hunger in the last 24 hours, and morning hunger) was assessed daily and scored separately using a numeric rating score for each from 0 to 10, with 0 = not hungry at all and 10 = hungriest possible.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged &lt; 12 Years</measure>
    <time_frame>Baseline, Month 3</time_frame>
    <description>The mean change in daily hunger questionnaire scores for participants &lt; 12 years of age with obesity in treatment with setmelanotide was evaluated. Hunger was assessed daily using a Daily Hunger Questionnaire with a pictorial (smiley face) version of the Likert rating scale with scores ranged from 0 to 4, with 0 = not hungry at all and 4 = hungriest possible.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years</measure>
    <time_frame>Baseline, Month 3</time_frame>
    <description>For participants ≥ 12 years of age, the following question was asked using the Global Hunger Questionnaire: Overall, how would you rate the hunger you experience now? Possible responses were: No hunger; Mild hunger; Moderate hunger; Severe hunger; and Not answered.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged &lt; 12 Years</measure>
    <time_frame>Baseline, Month 3</time_frame>
    <description>For participants &lt; 12 years of age, the following question was asked to parents or caregivers of participants using the Global Hunger Questionnaire: How hungry is your child acting now? Possible responses were: Not hungry at all; A little hungry; Moderately hungry; Extremely hungry; and Not answered.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Waist Circumference After 3 Months of Setmelanotide Treatment</measure>
    <time_frame>Baseline, Month 3</time_frame>
    <description>Waist circumference (cm) was measured according to the National Heart, Lung, and Blood Institute (NHLBI) criteria. All measurements were single measures. Waist circumference was measured when participants were in fasting condition and at approximately the same time at each visit.</description>
  </secondary_outcome>
  <number_of_arms>10</number_of_arms>
  <enrollment type="Actual">213</enrollment>
  <condition>Genetic Obesity</condition>
  <condition>Obesity</condition>
  <condition>Obesity Due to Melanocortin 4 Receptor Deficiency</condition>
  <arm_group>
    <arm_group_label>16p11.2 Cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with chromosomal rearrangement of the p11.2 region of chromosome 16 (16p11.2) locus causing obesity received setmelanotide once daily (QD) via subcutaneous (SC) injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AS Cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with Alström syndrome (AS) received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BBS Cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with Bardet-Biedl syndrome (BBS) received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MC4R Cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with melanocortin-4 receptor (MC4R) deficiency obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>POMC/PCSK1/LEPR Heterozygous Cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with pro-opiomelanocortin (POMC)/proprotein convertase subtilisin/kexin type 1 (PCSK1)/leptin receptor (LEPR) heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>POMC/PCSK1/LEPR Composite Heterozygous Cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with POMC/PCSK1/LEPR composite heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>POMC/PCSK1/LEPR Compound Heterozygous Cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with POMC/PCSK1/LEPR compound heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SH2B1 Cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with steroid receptor coactivator (SRC) homology 2B adapter protein 1 (SH2B1) haploinsufficiency received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SMS Cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with Smith-Magenis Syndrome (SMS) received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SRC1 Cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with steroid receptor coactivator 1 (SRC1) mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Setmelanotide</intervention_name>
    <description>RM-493 QD SC injection</description>
    <arm_group_label>16p11.2 Cohort</arm_group_label>
    <arm_group_label>AS Cohort</arm_group_label>
    <arm_group_label>BBS Cohort</arm_group_label>
    <arm_group_label>MC4R Cohort</arm_group_label>
    <arm_group_label>POMC/PCSK1/LEPR Composite Heterozygous Cohort</arm_group_label>
    <arm_group_label>POMC/PCSK1/LEPR Compound Heterozygous Cohort</arm_group_label>
    <arm_group_label>POMC/PCSK1/LEPR Heterozygous Cohort</arm_group_label>
    <arm_group_label>SH2B1 Cohort</arm_group_label>
    <arm_group_label>SMS Cohort</arm_group_label>
    <arm_group_label>SRC1 Cohort</arm_group_label>
    <other_name>RM-493</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Participants with the following genotypes and/or clinical assessment:&#xD;
&#xD;
               1. POMC/PCSK1/LEPR heterozygous - not currently enrolling new participants&#xD;
&#xD;
               2. POMC/PCSK1/LEPR compound heterozygous (two different mutations in gene) or&#xD;
                  homozygous deficiency obesity&#xD;
&#xD;
               3. POMC/PCSK1/LEPR composite heterozygous (two or more mutations in two or more&#xD;
                  genes) deficiency obesity&#xD;
&#xD;
               4. SMS&#xD;
&#xD;
               5. SH2B1 deficiency obesity&#xD;
&#xD;
               6. Chromosomal rearrangement of the 16p11.2 locus causing obesity&#xD;
&#xD;
               7. Carboxypeptidase E (CPE) compound heterozygous or homozygous deficiency obesity&#xD;
&#xD;
               8. Leptin deficiency obesity with loss of response to metreleptin&#xD;
&#xD;
               9. SRC1 deficiency obesity&#xD;
&#xD;
              10. MC4R deficiency obesity&#xD;
&#xD;
          2. Age 6 years and above&#xD;
&#xD;
          3. Obese, defined as Body Mass Index (BMI) ≥ 30 kilogram per meter square (kg/m^2) for&#xD;
             participants ≥16 years of age or BMI≥ 95th percentile for age and gender for&#xD;
             participants 6 up to 16 years of age.&#xD;
&#xD;
          4. Participant and/or parent or guardian is able to understand and comply with the&#xD;
             requirements of the study and is able to understand and sign the written informed&#xD;
             consent/assent&#xD;
&#xD;
          5. Female participants of childbearing potential must be confirmed non-pregnant, and&#xD;
             agree to use contraception as outlined in the protocol.&#xD;
&#xD;
          6. Male participants with female partners of childbearing potential must agree to a&#xD;
             double barrier method if they become sexually active during the study. Male&#xD;
             participants must not donate sperm during and for 90 days following their&#xD;
             participation in the study.&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          1. Recent intensive (within 2 months) diet and/or exercise regimen with or without the&#xD;
             use of weight loss agents that has resulted in &gt; 2% weight loss.&#xD;
&#xD;
          2. Use of any medication that is approved to treat obesity within three months of first&#xD;
             dose of study drug (e.g., orlistat, lorcaserin, phentermine-topiramate,&#xD;
             naltrexone-bupropion).&#xD;
&#xD;
          3. Gastric bypass surgery within the previous six months or any prior gastric bypass&#xD;
             surgery resulting in &gt;10% weight loss durably maintained&#xD;
&#xD;
          4. Diagnosis of schizophrenia, bipolar disorder, personality disorder, major depressive&#xD;
             disorder, or other psychiatric disorder(s)&#xD;
&#xD;
          5. Suicidal ideation, attempt or behavior&#xD;
&#xD;
          6. Clinically significant pulmonary, cardiac, or oncologic disease&#xD;
&#xD;
          7. hemoglobin A1c (HbA1c) &gt; 9.0% at Screening&#xD;
&#xD;
          8. History of significant liver disease&#xD;
&#xD;
          9. Glomerular filtration rate (GFR) &lt; 30 milliliter/minute (mL/min) at Screening.&#xD;
&#xD;
         10. History or close family history of melanoma or participant history of oculocutaneous&#xD;
             albinism&#xD;
&#xD;
         11. Significant dermatologic findings relating to melanoma or pre-melanoma skin lesions.&#xD;
&#xD;
         12. Participation in any clinical study with an investigational drug/device within 3&#xD;
             months prior to the first day of dosing.&#xD;
&#xD;
         13. Participants previously enrolled in a clinical study involving setmelanotide or any&#xD;
             previous exposure to setmelanotide.&#xD;
&#xD;
         14. Inability to comply with QD injection regimen.&#xD;
&#xD;
         15. Females who are breastfeeding or nursing.&#xD;
&#xD;
        Other protocol defined Inclusion/Exclusion criteria may apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Meeker, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Rhythm Pharmaceuticals, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc. - Simon Williamson Clinic, PC</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc. - Phoenix Southeast</name>
      <address>
        <city>Chandler</city>
        <state>Arizona</state>
        <zip>85224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc. - Central Arizona Medical Associates, PC</name>
      <address>
        <city>Mesa</city>
        <state>Arizona</state>
        <zip>85206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Honor Health Research Institute</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85258</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Axis Clinical Trials-Downtown</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Axis Clinical Trials Headquarters</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90036</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Diego Wake Research</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Anschutz Health and Wellness Center University of Colorado Anschutz Medical Campus</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Division of Endocrinology and Diabetes Children's National Hospital</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florida College of Medicine</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AXIS South Florida Clinical Trials</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Hospital</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc. - St. Petersburg</name>
      <address>
        <city>Pinellas Park</city>
        <state>Florida</state>
        <zip>33781</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc. - Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60602</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maine Medical Partners</name>
      <address>
        <city>Portland</city>
        <state>Maine</state>
        <zip>04102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NIH Hatfield Clinical Research Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baystate Medical Center</name>
      <address>
        <city>Springfield</city>
        <state>Massachusetts</state>
        <zip>01107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan Medicine</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Precision Medicine for Obesity Research: Gastroenterology &amp; Hepatology Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University St. Louis</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Impact Clinical Trials</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AXIS New York Clinical Trials</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University at Buffalo</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AXIS Clinical Trials</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Research Inc.</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc. - Akron</name>
      <address>
        <city>Akron</city>
        <state>Ohio</state>
        <zip>44311</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc. - Cincinnati</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc. - Columbus</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Obesity Institute, Geisinger Clinic</name>
      <address>
        <city>Danville</city>
        <state>Pennsylvania</state>
        <zip>17822</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Childrens Hospital of Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc. - Primary Care Associates, PC</name>
      <address>
        <city>Anderson</city>
        <state>South Carolina</state>
        <zip>29621</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Research TN</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37421</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Le Bonheur Children's Hospital</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University School of Medicine</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37212-3157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor College of Medicine</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc. - Plano</name>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc. - San Antonio</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seattle Children's Research Institute</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marshfield Clinic Research Institute</name>
      <address>
        <city>Marshfield</city>
        <state>Wisconsin</state>
        <zip>54449</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Alberta</name>
      <address>
        <city>Edmonton</city>
        <zip>T6G 2E1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Trousseau - Nutrition et Gastroentérologie</name>
      <address>
        <city>Paris</city>
        <zip>75012</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital de la Pitié-Salpêtrière</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de pédiatrie CHU de la Réunion - Hôpital Félix Guyon</name>
      <address>
        <city>Saint-Denis</city>
        <zip>97405</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charité Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>13354</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Leipzig</name>
      <address>
        <city>Leipzig</city>
        <zip>04103</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Ulm</name>
      <address>
        <city>Ulm</city>
        <zip>89075</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University General Hospital of Patras</name>
      <address>
        <city>Río</city>
        <state>Patras</state>
        <zip>26504</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Edmond and Lily Safra Children's Hospital</name>
      <address>
        <city>Ramat Gan</city>
        <zip>52621</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erasmus MC</name>
      <address>
        <city>Rotterdam</city>
        <zip>3015 CE</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Infantil Universitario Niño Jesús</name>
      <address>
        <city>Madrid</city>
        <zip>65 28009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Birmingham NHS Foundation Trust</name>
      <address>
        <city>Birmingham</city>
        <zip>B15 2TH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Addenbrooke's Hospital</name>
      <address>
        <city>Cambridge</city>
        <zip>CB2 0QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hammersmith Hospital</name>
      <address>
        <city>London</city>
        <zip>W12 0NN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hammersmith Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>France</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Israel</country>
    <country>Netherlands</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <results_first_submitted>July 25, 2023</results_first_submitted>
  <results_first_submitted_qc>July 25, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">August 18, 2023</results_first_posted>
  <last_update_submitted>July 25, 2023</last_update_submitted>
  <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pro-opiomelanocortin (POMC) deficiency obesity</keyword>
  <keyword>LepR deficiency obesity</keyword>
  <keyword>Smith-Magenis Syndrome</keyword>
  <keyword>MC4R deficiency obesity</keyword>
  <keyword>SRC1 deficiency obesity</keyword>
  <keyword>SH2B1 deficiency obesity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Genetic Diseases, Inborn</mesh_term>
    <mesh_term>Obesity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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>February 20, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/43/NCT03013543/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>September 21, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/43/NCT03013543/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Of the 218 participants screened, 213 participants were enrolled in the study.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>16p11.2 Cohort</title>
          <description>Participants with chromosomal rearrangement of the p11.2 region of chromosome 16 (16p11.2) locus causing obesity received setmelanotide once daily (QD) via subcutaneous (SC) injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
        </group>
        <group group_id="P2">
          <title>AS Cohort</title>
          <description>Participants with Alström syndrome (AS) received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
        </group>
        <group group_id="P3">
          <title>BBS Cohort</title>
          <description>Participants with Bardet-Biedl syndrome (BBS) received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
        </group>
        <group group_id="P4">
          <title>MC4R Cohort</title>
          <description>Participants with melanocortin-4 receptor (MC4R) deficiency obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
        </group>
        <group group_id="P5">
          <title>POMC/PCSK1/LEPR Heterozygous Cohort</title>
          <description>Participants with pro-opiomelanocortin (POMC)/proprotein convertase subtilisin/kexin type 1 (PCSK1)/leptin receptor (LEPR) heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
        </group>
        <group group_id="P6">
          <title>POMC/PCSK1/LEPR Composite Heterozygous Cohort</title>
          <description>Participants with POMC/PCSK1/LEPR composite heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
        </group>
        <group group_id="P7">
          <title>POMC/PCSK1/LEPR Compound Heterozygous Cohort</title>
          <description>Participants with POMC/PCSK1/LEPR compound heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
        </group>
        <group group_id="P8">
          <title>SH2B1 Cohort</title>
          <description>Participants with steroid receptor coactivator (SRC) homology 2B adapter protein 1 (SH2B1) haploinsufficiency received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
        </group>
        <group group_id="P9">
          <title>SMS Cohort</title>
          <description>Participants with Smith-Magenis Syndrome (SMS) received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
        </group>
        <group group_id="P10">
          <title>SRC1 Cohort</title>
          <description>Participants with steroid receptor coactivator 1 (SRC1) mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="10"/>
                <participants group_id="P4" count="49"/>
                <participants group_id="P5" count="33"/>
                <participants group_id="P6" count="5"/>
                <participants group_id="P7" count="27"/>
                <participants group_id="P8" count="22"/>
                <participants group_id="P9" count="12"/>
                <participants group_id="P10" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="37"/>
                <participants group_id="P5" count="22"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="20"/>
                <participants group_id="P8" count="13"/>
                <participants group_id="P9" count="9"/>
                <participants group_id="P10" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="12"/>
                <participants group_id="P5" count="11"/>
                <participants group_id="P6" count="3"/>
                <participants group_id="P7" count="7"/>
                <participants group_id="P8" count="9"/>
                <participants group_id="P9" count="3"/>
                <participants group_id="P10" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="5"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="3"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal By Parent/Guardian</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="3"/>
                <participants group_id="P8" count="8"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <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="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</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="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</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="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-Compliance With Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The Full Analysis Set (FAS) included all participants who received at least 1 dose of study drug and had baseline weight data.</population>
      <group_list>
        <group group_id="B1">
          <title>16p11.2 Cohort</title>
          <description>Participants with chromosomal rearrangement of the 16p11.2 locus causing obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
        </group>
        <group group_id="B2">
          <title>AS Cohort</title>
          <description>Participants with AS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
        </group>
        <group group_id="B3">
          <title>BBS Cohort</title>
          <description>Participants with BBS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
        </group>
        <group group_id="B4">
          <title>MC4R Cohort</title>
          <description>Participants with MC4R deficiency obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
        </group>
        <group group_id="B5">
          <title>POMC/PCSK1/LEPR Heterozygous Cohort</title>
          <description>Participants with PCSK1/LEPR heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
        </group>
        <group group_id="B6">
          <title>POMC/PCSK1/LEPR Composite Heterozygous Cohort</title>
          <description>Participants with POMC/PCSK1/LEPR composite heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
        </group>
        <group group_id="B7">
          <title>POMC/PCSK1/LEPR Compound Heterozygous Cohort</title>
          <description>Participants with POMC/PCSK1/LEPR compound heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
        </group>
        <group group_id="B8">
          <title>SH2B1 Cohort</title>
          <description>Participants with SH2B1 haploinsufficiency received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
        </group>
        <group group_id="B9">
          <title>SMS Cohort</title>
          <description>Participants with SMS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
        </group>
        <group group_id="B10">
          <title>SRC1 Cohort</title>
          <description>Participants with SRC1 mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</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="19"/>
            <count group_id="B2" value="4"/>
            <count group_id="B3" value="10"/>
            <count group_id="B4" value="49"/>
            <count group_id="B5" value="33"/>
            <count group_id="B6" value="5"/>
            <count group_id="B7" value="27"/>
            <count group_id="B8" value="22"/>
            <count group_id="B9" value="12"/>
            <count group_id="B10" value="32"/>
            <count group_id="B11" value="213"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21.4" spread="14.58"/>
                    <measurement group_id="B2" value="16.0" spread="3.74"/>
                    <measurement group_id="B3" value="22.5" spread="14.71"/>
                    <measurement group_id="B4" value="22.4" spread="15.28"/>
                    <measurement group_id="B5" value="36.1" spread="17.23"/>
                    <measurement group_id="B6" value="40.4" spread="19.62"/>
                    <measurement group_id="B7" value="30.7" spread="20.16"/>
                    <measurement group_id="B8" value="33.6" spread="17.88"/>
                    <measurement group_id="B9" value="19.4" spread="8.10"/>
                    <measurement group_id="B10" value="31.3" spread="17.13"/>
                    <measurement group_id="B11" value="28.1" spread="17.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="27"/>
                    <measurement group_id="B5" value="22"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="18"/>
                    <measurement group_id="B8" value="15"/>
                    <measurement group_id="B9" value="10"/>
                    <measurement group_id="B10" value="25"/>
                    <measurement group_id="B11" value="143"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="22"/>
                    <measurement group_id="B5" value="11"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="9"/>
                    <measurement group_id="B8" value="7"/>
                    <measurement group_id="B9" value="2"/>
                    <measurement group_id="B10" value="7"/>
                    <measurement group_id="B11" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="2"/>
                    <measurement group_id="B10" value="3"/>
                    <measurement group_id="B11" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="40"/>
                    <measurement group_id="B5" value="31"/>
                    <measurement group_id="B6" value="5"/>
                    <measurement group_id="B7" value="25"/>
                    <measurement group_id="B8" value="19"/>
                    <measurement group_id="B9" value="10"/>
                    <measurement group_id="B10" value="29"/>
                    <measurement group_id="B11" value="184"/>
                  </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="1"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <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="0"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="5"/>
                    <measurement group_id="B9" value="1"/>
                    <measurement group_id="B10" value="6"/>
                    <measurement group_id="B11" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="38"/>
                    <measurement group_id="B5" value="28"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="23"/>
                    <measurement group_id="B8" value="13"/>
                    <measurement group_id="B9" value="10"/>
                    <measurement group_id="B10" value="24"/>
                    <measurement group_id="B11" value="166"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="3"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="1"/>
                    <measurement group_id="B10" value="2"/>
                    <measurement group_id="B11" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Weight</title>
          <units>kilograms (kg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="113.62" spread="38.489"/>
                    <measurement group_id="B2" value="87.28" spread="16.360"/>
                    <measurement group_id="B3" value="128.04" spread="28.631"/>
                    <measurement group_id="B4" value="117.87" spread="32.339"/>
                    <measurement group_id="B5" value="143.04" spread="30.492"/>
                    <measurement group_id="B6" value="139.05" spread="30.957"/>
                    <measurement group_id="B7" value="122.08" spread="43.315"/>
                    <measurement group_id="B8" value="129.06" spread="39.480"/>
                    <measurement group_id="B9" value="92.48" spread="24.556"/>
                    <measurement group_id="B10" value="124.07" spread="33.717"/>
                    <measurement group_id="B11" value="122.98" spread="36.142"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Waist Circumference</title>
          <units>centimeters (cm)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="116.84" spread="22.179"/>
                    <measurement group_id="B2" value="109.75" spread="14.523"/>
                    <measurement group_id="B3" value="126.20" spread="19.344"/>
                    <measurement group_id="B4" value="122.52" spread="19.697"/>
                    <measurement group_id="B5" value="137.95" spread="18.529"/>
                    <measurement group_id="B6" value="134.00" spread="19.038"/>
                    <measurement group_id="B7" value="128.52" spread="28.772"/>
                    <measurement group_id="B8" value="130.28" spread="23.029"/>
                    <measurement group_id="B9" value="110.14" spread="11.807"/>
                    <measurement group_id="B10" value="123.10" spread="21.101"/>
                    <measurement group_id="B11" value="125.63" spread="22.162"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With ≥ 5% Reduction in Body Weight From Baseline After 3 Months of Setmelanotide Treatment</title>
        <time_frame>Baseline to Month 3</time_frame>
        <population>Participants in the FAS were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>16p11.2 Cohort</title>
            <description>Participants with chromosomal rearrangement of the 16p11.2 locus causing obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O2">
            <title>AS Cohort</title>
            <description>Participants with AS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O3">
            <title>BBS Cohort</title>
            <description>Participants with BBS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O4">
            <title>MC4R Cohort</title>
            <description>Participants with MC4R deficiency obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O5">
            <title>POMC/PCSK1/LEPR Heterozygous Cohort</title>
            <description>Participants with PCSK1/LEPR heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O6">
            <title>POMC/PCSK1/LEPR Composite Heterozygous Cohort</title>
            <description>Participants with POMC/PCSK1/LEPR composite heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O7">
            <title>POMC/PCSK1/LEPR Compound Heterozygous Cohort</title>
            <description>Participants with POMC/PCSK1/LEPR compound heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O8">
            <title>SH2B1 Cohort</title>
            <description>Participants with SH2B1 haploinsufficiency received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O9">
            <title>SMS Cohort</title>
            <description>Participants with SMS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O10">
            <title>SRC1 Cohort</title>
            <description>Participants with SRC1 mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With ≥ 5% Reduction in Body Weight From Baseline After 3 Months of Setmelanotide Treatment</title>
          <population>Participants in the FAS were analyzed.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="49"/>
                <count group_id="O5" value="33"/>
                <count group_id="O6" value="5"/>
                <count group_id="O7" value="27"/>
                <count group_id="O8" value="22"/>
                <count group_id="O9" value="12"/>
                <count group_id="O10" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="7"/>
                    <measurement group_id="O5" value="10"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="14"/>
                    <measurement group_id="O8" value="8"/>
                    <measurement group_id="O9" value="1"/>
                    <measurement group_id="O10" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment-Emergent Adverse Events (TEAEs)</title>
        <description>An adverse event (AE) was any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE (also referred to as an adverse experience) could be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality. TEAEs were defined as AEs reported after dosing on Day 1.</description>
        <time_frame>From first dose up to Month 16</time_frame>
        <population>Safety Analysis Set included all participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>16p11.2 Cohort</title>
            <description>Participants with chromosomal rearrangement of the 16p11.2 locus causing obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O2">
            <title>AS Cohort</title>
            <description>Participants with AS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O3">
            <title>BBS Cohort</title>
            <description>Participants with BBS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O4">
            <title>MC4R Cohort</title>
            <description>Participants with MC4R deficiency obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O5">
            <title>POMC/PCSK1/LEPR Heterozygous Cohort</title>
            <description>Participants with PCSK1/LEPR heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O6">
            <title>POMC/PCSK1/LEPR Composite Heterozygous Cohort</title>
            <description>Participants with POMC/PCSK1/LEPR composite heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O7">
            <title>POMC/PCSK1/LEPR Compound Heterozygous Cohort</title>
            <description>Participants with POMC/PCSK1/LEPR compound heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O8">
            <title>SH2B1 Cohort</title>
            <description>Participants with SH2B1 haploinsufficiency received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O9">
            <title>SMS Cohort</title>
            <description>Participants with SMS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O10">
            <title>SRC1 Cohort</title>
            <description>Participants with SRC1 mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-Emergent Adverse Events (TEAEs)</title>
          <description>An adverse event (AE) was any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE (also referred to as an adverse experience) could be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality. TEAEs were defined as AEs reported after dosing on Day 1.</description>
          <population>Safety Analysis Set included all participants who received at least 1 dose of study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="49"/>
                <count group_id="O5" value="33"/>
                <count group_id="O6" value="5"/>
                <count group_id="O7" value="27"/>
                <count group_id="O8" value="22"/>
                <count group_id="O9" value="12"/>
                <count group_id="O10" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="49"/>
                    <measurement group_id="O5" value="33"/>
                    <measurement group_id="O6" value="5"/>
                    <measurement group_id="O7" value="27"/>
                    <measurement group_id="O8" value="21"/>
                    <measurement group_id="O9" value="12"/>
                    <measurement group_id="O10" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Body Weight After 3 Months of Setmelanotide Treatment</title>
        <time_frame>Baseline, Month 3</time_frame>
        <population>Participants in the FAS were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>16p11.2 Cohort</title>
            <description>Participants with chromosomal rearrangement of the 16p11.2 locus causing obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O2">
            <title>AS Cohort</title>
            <description>Participants with AS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O3">
            <title>BBS Cohort</title>
            <description>Participants with BBS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O4">
            <title>MC4R Cohort</title>
            <description>Participants with MC4R deficiency obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O5">
            <title>POMC/PCSK1/LEPR Heterozygous Cohort</title>
            <description>Participants with PCSK1/LEPR heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O6">
            <title>POMC/PCSK1/LEPR Composite Heterozygous Cohort</title>
            <description>Participants with POMC/PCSK1/LEPR composite heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O7">
            <title>POMC/PCSK1/LEPR Compound Heterozygous Cohort</title>
            <description>Participants with POMC/PCSK1/LEPR compound heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O8">
            <title>SH2B1 Cohort</title>
            <description>Participants with SH2B1 haploinsufficiency received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O9">
            <title>SMS Cohort</title>
            <description>Participants with SMS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O10">
            <title>SRC1 Cohort</title>
            <description>Participants with SRC1 mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Body Weight After 3 Months of Setmelanotide Treatment</title>
          <population>Participants in the FAS were analyzed.</population>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="49"/>
                <count group_id="O5" value="33"/>
                <count group_id="O6" value="5"/>
                <count group_id="O7" value="27"/>
                <count group_id="O8" value="22"/>
                <count group_id="O9" value="12"/>
                <count group_id="O10" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.58" spread="4.886"/>
                    <measurement group_id="O2" value="-5.16" spread="3.860"/>
                    <measurement group_id="O3" value="-4.61" spread="7.771"/>
                    <measurement group_id="O4" value="-1.26" spread="4.851"/>
                    <measurement group_id="O5" value="-4.74" spread="7.689"/>
                    <measurement group_id="O6" value="-0.11" spread="2.432"/>
                    <measurement group_id="O7" value="-7.24" spread="6.657"/>
                    <measurement group_id="O8" value="-3.98" spread="5.164"/>
                    <measurement group_id="O9" value="-0.14" spread="2.805"/>
                    <measurement group_id="O10" value="-3.96" spread="4.370"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Body Weight After 3 Months of Setmelanotide Treatment</title>
        <time_frame>Baseline, Month 3</time_frame>
        <population>Participants in the FAS were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>16p11.2 Cohort</title>
            <description>Participants with chromosomal rearrangement of the 16p11.2 locus causing obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O2">
            <title>AS Cohort</title>
            <description>Participants with AS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O3">
            <title>BBS Cohort</title>
            <description>Participants with BBS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O4">
            <title>MC4R Cohort</title>
            <description>Participants with MC4R deficiency obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O5">
            <title>POMC/PCSK1/LEPR Heterozygous Cohort</title>
            <description>Participants with PCSK1/LEPR heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O6">
            <title>POMC/PCSK1/LEPR Composite Heterozygous Cohort</title>
            <description>Participants with POMC/PCSK1/LEPR composite heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O7">
            <title>POMC/PCSK1/LEPR Compound Heterozygous Cohort</title>
            <description>Participants with POMC/PCSK1/LEPR compound heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O8">
            <title>SH2B1 Cohort</title>
            <description>Participants with SH2B1 haploinsufficiency received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O9">
            <title>SMS Cohort</title>
            <description>Participants with SMS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O10">
            <title>SRC1 Cohort</title>
            <description>Participants with SRC1 mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Body Weight After 3 Months of Setmelanotide Treatment</title>
          <population>Participants in the FAS were analyzed.</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="49"/>
                <count group_id="O5" value="33"/>
                <count group_id="O6" value="5"/>
                <count group_id="O7" value="27"/>
                <count group_id="O8" value="22"/>
                <count group_id="O9" value="12"/>
                <count group_id="O10" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.19" spread="3.685"/>
                    <measurement group_id="O2" value="-6.38" spread="5.043"/>
                    <measurement group_id="O3" value="-4.19" spread="5.579"/>
                    <measurement group_id="O4" value="-0.75" spread="4.291"/>
                    <measurement group_id="O5" value="-3.50" spread="5.817"/>
                    <measurement group_id="O6" value="-0.31" spread="1.772"/>
                    <measurement group_id="O7" value="-5.57" spread="5.170"/>
                    <measurement group_id="O8" value="-2.92" spread="3.834"/>
                    <measurement group_id="O9" value="-0.00" spread="3.651"/>
                    <measurement group_id="O10" value="-3.34" spread="3.607"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years</title>
        <description>The mean change in daily hunger questionnaire scores for participants ≥ 12 years of age with obesity in treatment with setmelanotide was evaluated. On the Daily Hunger Questionnaire, each of the 3 items (average hunger in the last 24 hours, most/worst hunger in the last 24 hours, and morning hunger) was assessed daily and scored separately using a numeric rating score for each from 0 to 10, with 0 = not hungry at all and 10 = hungriest possible.</description>
        <time_frame>Baseline, Month 3</time_frame>
        <population>Participants aged ≥ 12 years in the FAS with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>16p11.2 Cohort</title>
            <description>Participants with chromosomal rearrangement of the 16p11.2 locus causing obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O2">
            <title>AS Cohort</title>
            <description>Participants with AS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O3">
            <title>BBS Cohort</title>
            <description>Participants with BBS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O4">
            <title>MC4R Cohort</title>
            <description>Participants with MC4R deficiency obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O5">
            <title>POMC/PCSK1/LEPR Heterozygous Cohort</title>
            <description>Participants with PCSK1/LEPR heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O6">
            <title>POMC/PCSK1/LEPR Composite Heterozygous Cohort</title>
            <description>Participants with POMC/PCSK1/LEPR composite heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O7">
            <title>POMC/PCSK1/LEPR Compound Heterozygous Cohort</title>
            <description>Participants with POMC/PCSK1/LEPR compound heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O8">
            <title>SH2B1 Cohort</title>
            <description>Participants with SH2B1 haploinsufficiency received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O9">
            <title>SMS Cohort</title>
            <description>Participants with SMS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O10">
            <title>SRC1 Cohort</title>
            <description>Participants with SRC1 mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years</title>
          <description>The mean change in daily hunger questionnaire scores for participants ≥ 12 years of age with obesity in treatment with setmelanotide was evaluated. On the Daily Hunger Questionnaire, each of the 3 items (average hunger in the last 24 hours, most/worst hunger in the last 24 hours, and morning hunger) was assessed daily and scored separately using a numeric rating score for each from 0 to 10, with 0 = not hungry at all and 10 = hungriest possible.</description>
          <population>Participants aged ≥ 12 years in the FAS with available data were analyzed.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="36"/>
                <count group_id="O5" value="31"/>
                <count group_id="O6" value="4"/>
                <count group_id="O7" value="17"/>
                <count group_id="O8" value="19"/>
                <count group_id="O9" value="0"/>
                <count group_id="O10" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline: Hunger Score on Average Last 24 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="36"/>
                    <count group_id="O5" value="31"/>
                    <count group_id="O6" value="4"/>
                    <count group_id="O7" value="17"/>
                    <count group_id="O8" value="19"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.11" spread="2.102"/>
                    <measurement group_id="O2" value="5.07" spread="1.860"/>
                    <measurement group_id="O3" value="6.37" spread="1.719"/>
                    <measurement group_id="O4" value="5.74" spread="1.915"/>
                    <measurement group_id="O5" value="5.73" spread="2.178"/>
                    <measurement group_id="O6" value="8.07" spread="1.348"/>
                    <measurement group_id="O7" value="6.32" spread="2.062"/>
                    <measurement group_id="O8" value="6.66" spread="1.966"/>
                    <measurement group_id="O10" value="6.04" spread="2.049"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 3: Hunger Score on Average Last 24 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="30"/>
                    <count group_id="O5" value="18"/>
                    <count group_id="O6" value="2"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="11"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.57" spread="2.602"/>
                    <measurement group_id="O2" value="-1.23" spread="2.739"/>
                    <measurement group_id="O3" value="-3.21" spread="2.858"/>
                    <measurement group_id="O4" value="-2.50" spread="2.278"/>
                    <measurement group_id="O5" value="-2.71" spread="1.946"/>
                    <measurement group_id="O6" value="-3.21" spread="2.525"/>
                    <measurement group_id="O7" value="-3.12" spread="1.911"/>
                    <measurement group_id="O8" value="-2.78" spread="2.639"/>
                    <measurement group_id="O10" value="-2.47" spread="2.003"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: Hunger Score at Most Hungry Last 24 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="36"/>
                    <count group_id="O5" value="31"/>
                    <count group_id="O6" value="4"/>
                    <count group_id="O7" value="17"/>
                    <count group_id="O8" value="19"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.23" spread="2.168"/>
                    <measurement group_id="O2" value="6.06" spread="2.185"/>
                    <measurement group_id="O3" value="7.50" spread="1.407"/>
                    <measurement group_id="O4" value="6.84" spread="1.866"/>
                    <measurement group_id="O5" value="6.95" spread="2.281"/>
                    <measurement group_id="O6" value="8.82" spread="0.936"/>
                    <measurement group_id="O7" value="7.45" spread="2.376"/>
                    <measurement group_id="O8" value="7.42" spread="1.870"/>
                    <measurement group_id="O10" value="6.91" spread="1.952"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 3: Hunger Score at Most Hungry Last 24 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="30"/>
                    <count group_id="O5" value="18"/>
                    <count group_id="O6" value="2"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="11"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.85" spread="2.561"/>
                    <measurement group_id="O2" value="-2.27" spread="3.656"/>
                    <measurement group_id="O3" value="-4.00" spread="2.717"/>
                    <measurement group_id="O4" value="-2.91" spread="2.155"/>
                    <measurement group_id="O5" value="-3.00" spread="2.264"/>
                    <measurement group_id="O6" value="-4.07" spread="2.929"/>
                    <measurement group_id="O7" value="-3.70" spread="2.501"/>
                    <measurement group_id="O8" value="-2.68" spread="2.915"/>
                    <measurement group_id="O10" value="-2.67" spread="2.241"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: Hunger Score in Morning</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="36"/>
                    <count group_id="O5" value="31"/>
                    <count group_id="O6" value="4"/>
                    <count group_id="O7" value="17"/>
                    <count group_id="O8" value="19"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.24" spread="2.508"/>
                    <measurement group_id="O2" value="4.98" spread="3.187"/>
                    <measurement group_id="O3" value="5.31" spread="2.705"/>
                    <measurement group_id="O4" value="3.99" spread="2.805"/>
                    <measurement group_id="O5" value="3.89" spread="2.589"/>
                    <measurement group_id="O6" value="7.04" spread="2.437"/>
                    <measurement group_id="O7" value="5.14" spread="2.537"/>
                    <measurement group_id="O8" value="4.96" spread="2.829"/>
                    <measurement group_id="O10" value="4.60" spread="2.924"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 3: Hunger Score in Morning</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="30"/>
                    <count group_id="O5" value="18"/>
                    <count group_id="O6" value="2"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="11"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.34" spread="3.390"/>
                    <measurement group_id="O2" value="-3.90" spread="4.195"/>
                    <measurement group_id="O3" value="-3.14" spread="3.173"/>
                    <measurement group_id="O4" value="-2.14" spread="2.914"/>
                    <measurement group_id="O5" value="-2.85" spread="2.084"/>
                    <measurement group_id="O6" value="-2.36" spread="1.111"/>
                    <measurement group_id="O7" value="-3.15" spread="1.781"/>
                    <measurement group_id="O8" value="-3.09" spread="1.961"/>
                    <measurement group_id="O10" value="-1.88" spread="1.942"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged &lt; 12 Years</title>
        <description>The mean change in daily hunger questionnaire scores for participants &lt; 12 years of age with obesity in treatment with setmelanotide was evaluated. Hunger was assessed daily using a Daily Hunger Questionnaire with a pictorial (smiley face) version of the Likert rating scale with scores ranged from 0 to 4, with 0 = not hungry at all and 4 = hungriest possible.</description>
        <time_frame>Baseline, Month 3</time_frame>
        <population>Participants &lt; 12 years of age in the FAS with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>16p11.2 Cohort</title>
            <description>Participants with chromosomal rearrangement of the 16p11.2 locus causing obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O2">
            <title>AS Cohort</title>
            <description>Participants with AS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O3">
            <title>BBS Cohort</title>
            <description>Participants with BBS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O4">
            <title>MC4R Cohort</title>
            <description>Participants with MC4R deficiency obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O5">
            <title>POMC/PCSK1/LEPR Heterozygous Cohort</title>
            <description>Participants with PCSK1/LEPR heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O6">
            <title>POMC/PCSK1/LEPR Composite Heterozygous Cohort</title>
            <description>Participants with POMC/PCSK1/LEPR composite heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O7">
            <title>POMC/PCSK1/LEPR Compound Heterozygous Cohort</title>
            <description>Participants with POMC/PCSK1/LEPR compound heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O8">
            <title>SH2B1 Cohort</title>
            <description>Participants with SH2B1 haploinsufficiency received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O9">
            <title>SMS Cohort</title>
            <description>Participants with SMS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O10">
            <title>SRC1 Cohort</title>
            <description>Participants with SRC1 mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged &lt; 12 Years</title>
          <description>The mean change in daily hunger questionnaire scores for participants &lt; 12 years of age with obesity in treatment with setmelanotide was evaluated. Hunger was assessed daily using a Daily Hunger Questionnaire with a pictorial (smiley face) version of the Likert rating scale with scores ranged from 0 to 4, with 0 = not hungry at all and 4 = hungriest possible.</description>
          <population>Participants &lt; 12 years of age in the FAS with available data were analyzed.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="0"/>
                <count group_id="O6" value="0"/>
                <count group_id="O7" value="3"/>
                <count group_id="O8" value="3"/>
                <count group_id="O9" value="0"/>
                <count group_id="O10" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline: Hunger Right Now</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="7"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="3"/>
                    <count group_id="O8" value="3"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.32" spread="0.741"/>
                    <measurement group_id="O4" value="2.02" spread="1.300"/>
                    <measurement group_id="O7" value="2.17" spread="1.443"/>
                    <measurement group_id="O8" value="1.87" spread="0.125"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 3: Hunger Right Now</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="7"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="3"/>
                    <count group_id="O8" value="2"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.57" spread="0.261"/>
                    <measurement group_id="O4" value="-0.72" spread="1.346"/>
                    <measurement group_id="O7" value="-1.55" spread="0.910"/>
                    <measurement group_id="O8" value="-1.44" spread="0.387"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years</title>
        <description>For participants ≥ 12 years of age, the following question was asked using the Global Hunger Questionnaire: Overall, how would you rate the hunger you experience now? Possible responses were: No hunger; Mild hunger; Moderate hunger; Severe hunger; and Not answered.</description>
        <time_frame>Baseline, Month 3</time_frame>
        <population>Participants ≥ 12 years of age in the FAS with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>16p11.2 Cohort</title>
            <description>Participants with chromosomal rearrangement of the 16p11.2 locus causing obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O2">
            <title>AS Cohort</title>
            <description>Participants with AS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O3">
            <title>BBS Cohort</title>
            <description>Participants with BBS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O4">
            <title>MC4R Cohort</title>
            <description>Participants with MC4R deficiency obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O5">
            <title>POMC/PCSK1/LEPR Heterozygous Cohort</title>
            <description>Participants with PCSK1/LEPR heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O6">
            <title>POMC/PCSK1/LEPR Composite Heterozygous Cohort</title>
            <description>Participants with POMC/PCSK1/LEPR composite heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O7">
            <title>POMC/PCSK1/LEPR Compound Heterozygous Cohort</title>
            <description>Participants with POMC/PCSK1/LEPR compound heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O8">
            <title>SH2B1 Cohort</title>
            <description>Participants with SH2B1 haploinsufficiency received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O9">
            <title>SMS Cohort</title>
            <description>Participants with SMS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O10">
            <title>SRC1 Cohort</title>
            <description>Participants with SRC1 mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years</title>
          <description>For participants ≥ 12 years of age, the following question was asked using the Global Hunger Questionnaire: Overall, how would you rate the hunger you experience now? Possible responses were: No hunger; Mild hunger; Moderate hunger; Severe hunger; and Not answered.</description>
          <population>Participants ≥ 12 years of age in the FAS with available data were analyzed.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="27"/>
                <count group_id="O5" value="16"/>
                <count group_id="O6" value="1"/>
                <count group_id="O7" value="17"/>
                <count group_id="O8" value="10"/>
                <count group_id="O9" value="8"/>
                <count group_id="O10" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>No hunger (Baseline) - No hunger (Month 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No hunger (Baseline) - Mild hunger (Month 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No hunger (Baseline) - Moderate hunger (Month 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No hunger (Baseline) - Severe hunger (Month 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No hunger (Baseline) - Not answered (Month 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mild hunger (Baseline) - No hunger (Month 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="2"/>
                    <measurement group_id="O8" value="3"/>
                    <measurement group_id="O9" value="1"/>
                    <measurement group_id="O10" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mild hunger (Baseline) - Mild hunger (Month 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="5"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="4"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="1"/>
                    <measurement group_id="O10" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mild hunger (Baseline) - Moderate hunger (Month 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="1"/>
                    <measurement group_id="O10" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mild hunger (Baseline) - Severe hunger (Month 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mild hunger (Baseline) - Not answered (Month 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate hunger (Baseline) - No hunger (Month 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="1"/>
                    <measurement group_id="O9" value="1"/>
                    <measurement group_id="O10" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate hunger (Baseline) - Mild hunger (Month 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="5"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="4"/>
                    <measurement group_id="O8" value="3"/>
                    <measurement group_id="O9" value="1"/>
                    <measurement group_id="O10" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate hunger (Baseline) - Moderate hunger (Month 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate hunger (Baseline) - Severe hunger (Month 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate hunger (Baseline) - Not answered (Month 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe hunger (Baseline) - No hunger (Month 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="2"/>
                    <measurement group_id="O8" value="1"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe hunger (Baseline) - Mild hunger (Month 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="5"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="2"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe hunger (Baseline) - Moderate hunger (Month 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="2"/>
                    <measurement group_id="O10" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe hunger (Baseline) - Severe hunger (Month 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="2"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="1"/>
                    <measurement group_id="O10" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe hunger (Baseline) - Not answered (Month 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not answered (Baseline) - No hunger (Month 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not answered (Baseline) - Mild hunger (Month 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not answered (Baseline) - Moderate hunger (Month 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not answered (Baseline) - Severe hunger (Month 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not answered (Baseline) - Not answered (Month 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged &lt; 12 Years</title>
        <description>For participants &lt; 12 years of age, the following question was asked to parents or caregivers of participants using the Global Hunger Questionnaire: How hungry is your child acting now? Possible responses were: Not hungry at all; A little hungry; Moderately hungry; Extremely hungry; and Not answered.</description>
        <time_frame>Baseline, Month 3</time_frame>
        <population>Participants &lt; 12 years of age in the FAS with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>16p11.2 Cohort</title>
            <description>Participants with chromosomal rearrangement of the 16p11.2 locus causing obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O2">
            <title>AS Cohort</title>
            <description>Participants with AS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O3">
            <title>BBS Cohort</title>
            <description>Participants with BBS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O4">
            <title>MC4R Cohort</title>
            <description>Participants with MC4R deficiency obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O5">
            <title>POMC/PCSK1/LEPR Heterozygous Cohort</title>
            <description>Participants with PCSK1/LEPR heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O6">
            <title>POMC/PCSK1/LEPR Composite Heterozygous Cohort</title>
            <description>Participants with POMC/PCSK1/LEPR composite heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O7">
            <title>POMC/PCSK1/LEPR Compound Heterozygous Cohort</title>
            <description>Participants with POMC/PCSK1/LEPR compound heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O8">
            <title>SH2B1 Cohort</title>
            <description>Participants with SH2B1 haploinsufficiency received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O9">
            <title>SMS Cohort</title>
            <description>Participants with SMS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O10">
            <title>SRC1 Cohort</title>
            <description>Participants with SRC1 mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged &lt; 12 Years</title>
          <description>For participants &lt; 12 years of age, the following question was asked to parents or caregivers of participants using the Global Hunger Questionnaire: How hungry is your child acting now? Possible responses were: Not hungry at all; A little hungry; Moderately hungry; Extremely hungry; and Not answered.</description>
          <population>Participants &lt; 12 years of age in the FAS with available data were analyzed.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="0"/>
                <count group_id="O6" value="1"/>
                <count group_id="O7" value="2"/>
                <count group_id="O8" value="2"/>
                <count group_id="O9" value="0"/>
                <count group_id="O10" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Not hungry at all (Baseline) - Not hungry at all (Month 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O10" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not hungry at all (Baseline) - A little hungry (Month 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O10" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not hungry at all (Baseline) - Moderately hungry (Month 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O10" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not hungry at all (Baseline) - Extremely hungry (Month 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O10" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not hungry at all (Baseline) - Not answered (Month 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O10" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A little hungry (Baseline) - Not hungry at all (Month 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O10" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A little hungry (Baseline) - A little hungry (Month 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="2"/>
                    <measurement group_id="O8" value="1"/>
                    <measurement group_id="O10" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A little hungry (Baseline) - Moderately hungry (Month 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O10" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A little hungry (Baseline) - Extremely hungry (Month 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O10" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A little hungry (Baseline) - Not answered (Month 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O10" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderately hungry (Baseline) - Not hungry at all (Month 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O10" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderately hungry (Baseline) - A little hungry (Month 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O10" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderately hungry (Baseline) - Moderately hungry (Month 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="1"/>
                    <measurement group_id="O10" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderately hungry (Baseline) - Extremely hungry (Month 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O10" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderately hungry (Baseline) - Not answered (Month 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O10" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extremely hungry (Baseline) - Not hungry at all (Month 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O10" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extremely hungry (Baseline) - A little hungry (Month 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O10" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extremely hungry (Baseline) - Moderately hungry (Month 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O10" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extremely hungry (Baseline) - Extremely hungry (Month 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O10" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extremely hungry (Baseline) - Not answered (Month 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O10" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not answered (Baseline) - Not hungry at all (Month 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O10" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not answered (Baseline) - A little hungry (Month 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O10" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not answered (Baseline) - Moderately hungry (Month 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O10" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not answered (Baseline) - Extremely hungry (Month 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O10" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not answered (Baseline) - Not answered (Month 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O10" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Waist Circumference After 3 Months of Setmelanotide Treatment</title>
        <description>Waist circumference (cm) was measured according to the National Heart, Lung, and Blood Institute (NHLBI) criteria. All measurements were single measures. Waist circumference was measured when participants were in fasting condition and at approximately the same time at each visit.</description>
        <time_frame>Baseline, Month 3</time_frame>
        <population>Participants in the FAS with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>16p11.2 Cohort</title>
            <description>Participants with chromosomal rearrangement of the 16p11.2 locus causing obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O2">
            <title>AS Cohort</title>
            <description>Participants with AS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O3">
            <title>BBS Cohort</title>
            <description>Participants with BBS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O4">
            <title>MC4R Cohort</title>
            <description>Participants with MC4R deficiency obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O5">
            <title>POMC/PCSK1/LEPR Heterozygous Cohort</title>
            <description>Participants with PCSK1/LEPR heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O6">
            <title>POMC/PCSK1/LEPR Composite Heterozygous Cohort</title>
            <description>Participants with POMC/PCSK1/LEPR composite heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O7">
            <title>POMC/PCSK1/LEPR Compound Heterozygous Cohort</title>
            <description>Participants with POMC/PCSK1/LEPR compound heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O8">
            <title>SH2B1 Cohort</title>
            <description>Participants with SH2B1 haploinsufficiency received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O9">
            <title>SMS Cohort</title>
            <description>Participants with SMS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
          <group group_id="O10">
            <title>SRC1 Cohort</title>
            <description>Participants with SRC1 mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Waist Circumference After 3 Months of Setmelanotide Treatment</title>
          <description>Waist circumference (cm) was measured according to the National Heart, Lung, and Blood Institute (NHLBI) criteria. All measurements were single measures. Waist circumference was measured when participants were in fasting condition and at approximately the same time at each visit.</description>
          <population>Participants in the FAS with available data were analyzed.</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="36"/>
                <count group_id="O5" value="15"/>
                <count group_id="O6" value="2"/>
                <count group_id="O7" value="21"/>
                <count group_id="O8" value="13"/>
                <count group_id="O9" value="6"/>
                <count group_id="O10" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.00" spread="6.250"/>
                    <measurement group_id="O2" value="-6.60" spread="6.828"/>
                    <measurement group_id="O3" value="-4.92" spread="7.191"/>
                    <measurement group_id="O4" value="-0.61" spread="11.311"/>
                    <measurement group_id="O5" value="-1.09" spread="8.250"/>
                    <measurement group_id="O6" value="5.11" spread="8.412"/>
                    <measurement group_id="O7" value="-5.59" spread="6.554"/>
                    <measurement group_id="O8" value="-4.91" spread="8.495"/>
                    <measurement group_id="O9" value="-3.83" spread="8.543"/>
                    <measurement group_id="O10" value="-2.88" spread="4.632"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From first dose up to Month 16</time_frame>
      <desc>Participants in the Safety Analysis Set were analyzed.</desc>
      <group_list>
        <group group_id="E1">
          <title>16p11.2 Cohort</title>
          <description>Participants with chromosomal rearrangement of the 16p11.2 locus causing obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
        </group>
        <group group_id="E2">
          <title>AS Cohort</title>
          <description>Participants with AS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
        </group>
        <group group_id="E3">
          <title>BBS Cohort</title>
          <description>Participants with BBS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
        </group>
        <group group_id="E4">
          <title>MC4R Cohort</title>
          <description>Participants with MC4R deficiency obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
        </group>
        <group group_id="E5">
          <title>POMC/PCSK1/LEPR Heterozygous Cohort</title>
          <description>Participants with PCSK1/LEPR heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
        </group>
        <group group_id="E6">
          <title>POMC/PCSK1/LEPR Composite Heterozygous Cohort</title>
          <description>Participants with POMC/PCSK1/LEPR composite heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
        </group>
        <group group_id="E7">
          <title>POMC/PCSK1/LEPR Compound Heterozygous Cohort</title>
          <description>Participants with POMC/PCSK1/LEPR compound heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
        </group>
        <group group_id="E8">
          <title>SH2B1 Cohort</title>
          <description>Participants with SH2B1 haploinsufficiency received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
        </group>
        <group group_id="E9">
          <title>SMS Cohort</title>
          <description>Participants with SMS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
        </group>
        <group group_id="E10">
          <title>SRC1 Cohort</title>
          <description>Participants with SRC1 mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 23.0</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="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Myocardial Infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Rotavirus Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Melanocytic Naevus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Typical Aura Without Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 23.0</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="19" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="48" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="33" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="27" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="21" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="12" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="29" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Eosinophilia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Iron Deficiency Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Monocytosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>White Blood Cell Disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Bundle Branch Block Right</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Extrasystoles</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Tricuspid Valve Incompetence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Ventricular Extrasystoles</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Developmental Hip Dysplasia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Tinnitus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Excessive Cerumen Production</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Middle Ear Effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Otorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Goitre</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Hyperthyroidism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Hypogonadism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Age-Related Macular Degeneration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Blepharal Pigmentation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Exophthalmos</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Eye Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Eye Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Eye Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Eyelid Exfoliation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Myopia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Visual Impairment</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="12" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="14" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="13" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="13" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="11" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="6" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="6" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="4" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="4" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Abdominal Pain Upper</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Abdominal Discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Dry Mouth</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Abdominal Pain Lower</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal Reflux Disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Abdominal Distension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Abnormal Faeces</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Coeliac Disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Eructation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Gingival Hypertrophy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Odynophagia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Peptic Ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Pigmentation Lip</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Rectal Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Salivary Hypersecretion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Tooth Discolouration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection Site Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="8" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Injection Site Erythema</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="8" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="11" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="7" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="4" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Injection Site Induration</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Injection Site Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Injection Site Oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Injection Site Bruising</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Influenza Like Illness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Injection Site Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Chest Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Temperature Intolerance</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Non-Cardiac Chest Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Feeling Cold</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Injection Site Discolouration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Injection Site Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Injection Site Hypertrophy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Injection Site Inflammation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Injection Site Swelling</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Oedema Peripheral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Peripheral Swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Chest Discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Cyst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Feeling Jittery</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Impaired Healing</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Inflammation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Injection Site Discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Injection Site Dryness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Injection Site Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Injection Site Scab</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Injection Site Warmth</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Localised Oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Thirst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatic Steatosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaphylactic Reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Immunisation Reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Covid-19</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Viral Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Ear Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Tooth Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Skin Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Fungal Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Gastroenteritis Viral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Lower Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Otitis Externa</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Paronychia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Pharyngotonsillitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Wound Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Acute Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Asymptomatic Covid-19</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Bacterial Vaginosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Candida Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Conjunctivitis Bacterial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Hordeolum</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Impetigo</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Localised Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Mastoiditis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Nail Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Otitis Media</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Otitis Media Acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Pharyngitis Streptococcal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Tinea Versicolour</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Vaginal Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arthropod Sting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Ligament Sprain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Muscle Strain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Skin Abrasion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Thermal Burn</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Animal Scratch</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Ankle Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Bone Contusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Hand Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Limb Injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Oral Contusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Procedural Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Skin Laceration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Wound</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Wrist Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood Creatine Phosphokinase Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Alanine Aminotransferase Increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Aspartate Aminotransferase Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Low Density Lipoprotein Increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Urine Analysis Abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Blood Bilirubin Increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Blood Lactate Dehydrogenase Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Blood Pressure Increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Blood Triglycerides Increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>C-Reactive Protein Increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Culture Urine Positive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Sars-Cov-2 Test Positive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Bilirubin Conjugated Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Blood Alkaline Phosphatase Increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Blood Cholesterol Abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Blood Cholesterol Increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Blood Creatinine Increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Blood Lactate Dehydrogenase Decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Blood Urine Present</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>C-Reactive Protein Decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Coagulation Test Abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Forced Vital Capacity Decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Gamma-Glutamyltransferase Increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Glucose Urine Present</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>High Density Lipoprotein Decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>International Normalised Ratio Increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Protein Total Decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Thyroid Function Test Abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Total Cholesterol/Hdl Ratio Abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Transaminases Increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Urobilinogen Urine Increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased Appetite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Dyslipidaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Hypertriglyceridaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Hyperuricaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Vitamin D Deficiency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Food Craving</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Glucose Tolerance Impaired</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Impaired Fasting Glucose</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Abnormal Loss Of Weight</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Acidosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Hypercholesterolaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Hyperphosphataemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Increased Appetite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Starvation Ketoacidosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Vitamin B12 Deficiency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Pain In Extremity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Muscle Spasms</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Neck Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Flank Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Muscular Weakness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Musculoskeletal Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Dupuytren's Contracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Intervertebral Disc Degeneration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Muscle Tightness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Pain In Jaw</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Rhabdomyolysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Spinal Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Spinal Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Tendon Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Tendonitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Trigger Finger</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Trismus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Melanocytic Naevus</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="14" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="10" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="5" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="8" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Dysplastic Naevus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Skin Papilloma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Basal Cell Carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Eye Naevus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Fibroma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Sweat Gland Tumour</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Uterine Leiomyoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="10" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="8" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="13" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="10" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="7" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Dyskinesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Taste Disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Ageusia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Anosmia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Carpal Tunnel Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Hyperaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Lumbar Radiculopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Nystagmus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Parosmia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Poor Quality Sleep</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Pregnancy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Libido Increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Libido Decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Depressed Mood</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Nightmare</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Sleep Disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Terminal Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Abnormal Dreams</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Affect Lability</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Aggression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Behaviour Disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Mood Altered</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Panic Attack</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Psychological Factor Affecting Medical Condition</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Restlessness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Thinking Abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Leukocyturia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Urine Abnormality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Erection Increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Dysmenorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Genital Hyperaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Spontaneous Penile Erection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Erectile Dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Breast Discharge</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Breast Mass</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Dyspareunia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Female Sexual Arousal Disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Genital Disorder Female</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Genital Dysaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Labia Enlarged</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Menstruation Irregular</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Polymenorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Vaginal Discharge</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Vaginal Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Nasal Congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Rhinitis Allergic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Dyspnoea Exertional</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Yawning</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Dysphonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Oropharyngeal Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Pulmonary Mass</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Respiratory Distress</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Throat Irritation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin Hyperpigmentation</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="40" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="19" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="21" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="16" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="10" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="23" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Macule</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Lentigo</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Ephelides</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Papule</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Skin Discolouration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Nail Pigmentation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Skin Striae</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Acanthosis Nigricans</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Melanoderma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Nail Discolouration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Decubitus Ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Dry Skin</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Ingrowing Nail</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Lipodystrophy Acquired</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Pigmentation Disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Post Inflammatory Pigmentation Change</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Psoriasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Rash Erythematous</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Rash Papular</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Skin Depigmentation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Skin Lesion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Butterfly Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Dermatitis Acneiform</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Dermatitis Allergic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Dermatitis Atopic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Dermatitis Contact</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Diffuse Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Hair Colour Changes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Hyperkeratosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Ingrown Hair</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Keloid Scar</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Leukoderma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Nail Disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Nail Dystrophy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Night Sweats</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Photosensitivity Reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Pityriasis Alba</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Skin Exfoliation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Skin Irritation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Skin Plaque</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Skin Sensitisation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Solar Lentigo</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Solar Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Urticaria Thermal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Cataract Operation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Hot Flush</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="32"/>
              </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>All information regarding setmelanotide supplied by Rhythm to the investigator is privileged and confidential information. The investigator agrees to use this information to accomplish the study and will not use it for other purposes without consent from Rhythm. The information obtained from the clinical study will be used towards the development of setmelanotide and may be disclosed to regulatory authority(ies), other investigators, corporate partners, or consultants as required.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Rhythm Clinical Trials</name_or_title>
      <organization>Rhythm Pharmaceuticals, Inc.</organization>
      <phone>857-264-4280</phone>
      <email>clinicaltrials@rhythmtx.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/NCT03013543
org study id: RM-493-014
secondary id: 2017-000387-14
nct id: NCT03013543
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of the study was to determine the effect of setmelanotide (RM-493) on weight,
      hunger assessments, and other factors in participants with rare genetic disorders of obesity.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With ≥ 5% Reduction in Body Weight From Baseline After 3 Months of Setmelanotide Treatment
time frame: Baseline to Month 3
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
time frame: From first dose up to Month 16
description: An adverse event (AE) was any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE (also referred to as an adverse experience) could be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality. TEAEs were defined as AEs reported after dosing on Day 1.
measure: Change From Baseline in Body Weight After 3 Months of Setmelanotide Treatment
time frame: Baseline, Month 3
measure: Percent Change From Baseline in Body Weight After 3 Months of Setmelanotide Treatment
time frame: Baseline, Month 3
measure: Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years
time frame: Baseline, Month 3
description: The mean change in daily hunger questionnaire scores for participants ≥ 12 years of age with obesity in treatment with setmelanotide was evaluated. On the Daily Hunger Questionnaire, each of the 3 items (average hunger in the last 24 hours, most/worst hunger in the last 24 hours, and morning hunger) was assessed daily and scored separately using a numeric rating score for each from 0 to 10, with 0 = not hungry at all and 10 = hungriest possible.
measure: Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years
time frame: Baseline, Month 3
description: The mean change in daily hunger questionnaire scores for participants < 12 years of age with obesity in treatment with setmelanotide was evaluated. Hunger was assessed daily using a Daily Hunger Questionnaire with a pictorial (smiley face) version of the Likert rating scale with scores ranged from 0 to 4, with 0 = not hungry at all and 4 = hungriest possible.
measure: Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years
time frame: Baseline, Month 3
description: For participants ≥ 12 years of age, the following question was asked using the Global Hunger Questionnaire: Overall, how would you rate the hunger you experience now? Possible responses were: No hunger; Mild hunger; Moderate hunger; Severe hunger; and Not answered.
measure: Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years
time frame: Baseline, Month 3
description: For participants < 12 years of age, the following question was asked to parents or caregivers of participants using the Global Hunger Questionnaire: How hungry is your child acting now? Possible responses were: Not hungry at all; A little hungry; Moderately hungry; Extremely hungry; and Not answered.
measure: Percent Change From Baseline in Waist Circumference After 3 Months of Setmelanotide Treatment
time frame: Baseline, Month 3
description: Waist circumference (cm) was measured according to the National Heart, Lung, and Blood Institute (NHLBI) criteria. All measurements were single measures. Waist circumference was measured when participants were in fasting condition and at approximately the same time at each visit.
arm group label: 16p11.2 Cohort
arm group type: Experimental
description: Participants with chromosomal rearrangement of the p11.2 region of chromosome 16 (16p11.2) locus causing obesity received setmelanotide once daily (QD) via subcutaneous (SC) injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
arm group label: AS Cohort
arm group type: Experimental
description: Participants with Alström syndrome (AS) received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
arm group label: BBS Cohort
arm group type: Experimental
description: Participants with Bardet-Biedl syndrome (BBS) received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
arm group label: MC4R Cohort
arm group type: Experimental
description: Participants with melanocortin-4 receptor (MC4R) deficiency obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
arm group label: POMC/PCSK1/LEPR Heterozygous Cohort
arm group type: Experimental
description: Participants with pro-opiomelanocortin (POMC)/proprotein convertase subtilisin/kexin type 1 (PCSK1)/leptin receptor (LEPR) heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
arm group label: POMC/PCSK1/LEPR Composite Heterozygous Cohort
arm group type: Experimental
description: Participants with POMC/PCSK1/LEPR composite heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
arm group label: POMC/PCSK1/LEPR Compound Heterozygous Cohort
arm group type: Experimental
description: Participants with POMC/PCSK1/LEPR compound heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
arm group label: SH2B1 Cohort
arm group type: Experimental
description: Participants with steroid receptor coactivator (SRC) homology 2B adapter protein 1 (SH2B1) haploinsufficiency received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
arm group label: SMS Cohort
arm group type: Experimental
description: Participants with Smith-Magenis Syndrome (SMS) received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
arm group label: SRC1 Cohort
arm group type: Experimental
description: Participants with steroid receptor coactivator 1 (SRC1) mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
intervention type: Drug
intervention name: Setmelanotide
description: RM-493 QD SC injection
arm group label: 16p11.2 Cohort
arm group label: AS Cohort
arm group label: BBS Cohort
arm group label: MC4R Cohort
arm group label: POMC/PCSK1/LEPR Composite Heterozygous Cohort
arm group label: POMC/PCSK1/LEPR Compound Heterozygous Cohort
arm group label: POMC/PCSK1/LEPR Heterozygous Cohort
arm group label: SH2B1 Cohort
arm group label: SMS Cohort
arm group label: SRC1 Cohort
other name: RM-493
criteria: 
gender: All
minimum age: 6 Years
maximum age: N/A
healthy volunteers: No
last name: David Meeker, MD
role: Study Chair
affiliation: Rhythm Pharmaceuticals, Inc.
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country: Canada
country: France
country: Germany
country: Greece
country: Israel
country: Netherlands
country: Spain
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Genetic Diseases, Inborn
mesh term: Obesity
sharing ipd: No
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