<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/NCT01683409</url>
  </required_header>
  <id_info>
    <org_study_id>14734</org_study_id>
    <secondary_id>I4V-MC-JAGQ</secondary_id>
    <nct_id>NCT01683409</nct_id>
  </id_info>
  <brief_title>A Study to Test Safety and Efficacy of Baricitinib in Participants With Diabetic Kidney Disease</brief_title>
  <official_title>A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Phase 2 Study to Evaluate the Safety and Renal Efficacy of Baricitinib in Patients With Diabetic Kidney Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Incyte Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Eli Lilly and Company</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a dose ranging study to evaluate the safety and efficacy of baricitinib in the&#xD;
      treatment of participants with mild to moderate diabetic kidney disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Urinary Albumin/Creatinine Ratio (UACR) at Week 24</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>UACR is a potential marker of chronic kidney disease, calculated as a ratio of Urinary Albumin and Urinary Creatinine. The least squares mean (LS mean) are from mixed model repeated measures (MMRM) analyses which include treatment, baseline estimated Glomerular Filtration Rate (eGFR) group (higher: 50 to 70 mL/min/1.73m² and lower: 25 to &lt;50 mL/min/1.73m²), visit, treatment-by-visit interaction, baseline UACR, and baseline UACR-by-visit interaction.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Urinary Monocyte Chemotactic Protein 1 (MCP-1)/Creatinine Ratio</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Creatinine Clearance at Week 24</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>Creatinine clearance is the amount of creatinine cleared from kidney within 24 hours. The LS mean was from MMRM analyses which included treatment, baseline eGRF group, visit, treatment-by-visit interaction, baseline Creatinine Clearance, and baseline Creatinine Clearance-by-visit interaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) at Week 24</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>EQ-5D-5L is a 2-part measurement. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state. The second part is assessed using a visual analog scale (VAS) that ranged from 0 to 100mm, where 0 is the worst health you can imagine and 100 is the best health you can imagine. The LS means are analyzed using an analysis of covariance (ANCOVA) model with treatment, baseline eGFR group, and baseline VAS score or baseline health state index score as covariates.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK): Area Under the Concentration-Time Curve at Steady State (AUC,ss)</measure>
    <time_frame>Weeks 2 and 4 (1-2 hours postdose), 8 (3-6 hours postdose), 12 (in fasted state), 16 and 20 (6-9 hours postdose), 24 (in fasted state)</time_frame>
    <description>Evaluable pharmacokinetic concentrations from the 2-week, 4-week, 8-week, 12-week, 16-week, 20-week and 24-week time points were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state.</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">130</enrollment>
  <condition>Diabetic Kidney Disease</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Administered orally, given as three placebo tablets in the morning and one placebo tablet in the evening for 24 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Baricitinib 0.75 mg/0.5 mg QD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administered orally, 0.75 mg given as one 0.75 mg tablets and two placebo tablets in the morning and one placebo tablet in the evening for 24 weeks or 0.5 mg given as one 0.5 mg tablet and two placebo tablets in the morning and one placebo tablet in the evening for 24 weeks. Placebo tablets given to maintain blind.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Baricitinib 0.75 mg/0.5 mg BID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administered orally, 0.75 mg given as one 0.75 tablet and 2 placebo in the morning and one 0.75 mg tablet in the evening for 24 weeks or 0.5 mg given as one 0.5 mg tablet and two placebo tablets in the morning and one 0.5 mg tablet in the evening. Placebo tablets given to maintain blind.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Baricitinib 1.5 mg/1 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administered orally, 1.5 mg given as two 0.75 mg tablets and 1 placebo tablet in the morning and one placebo tablet in the evening for 24 weeks or 1 mg tablet and two placebo tablets in the morning and one placebo tablet in the evening for 24 weeks. Placebo tablets given to maintain blind.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Baricitinib 4 mg/2.75 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administered orally, 4 mg given as one tablet and 2 placebo tablets in the morning and one placebo tablet in the evening for 24 weeks or 2.75 mg given as two 1 mg tablets and one 0.75 mg tablet in the morning and one placebo tablet in the evening for 24 weeks. Placebo tablets given to maintain blind.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Baricitinib</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>Baricitinib 0.75 mg/0.5 mg BID</arm_group_label>
    <arm_group_label>Baricitinib 0.75 mg/0.5 mg QD</arm_group_label>
    <arm_group_label>Baricitinib 1.5 mg/1 mg</arm_group_label>
    <arm_group_label>Baricitinib 4 mg/2.75 mg</arm_group_label>
    <other_name>LY3009104</other_name>
    <other_name>INCB28050</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>Baricitinib 0.75 mg/0.5 mg BID</arm_group_label>
    <arm_group_label>Baricitinib 0.75 mg/0.5 mg QD</arm_group_label>
    <arm_group_label>Baricitinib 1.5 mg/1 mg</arm_group_label>
    <arm_group_label>Baricitinib 4 mg/2.75 mg</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants with Type 2 diabetes treated with at least one antihyperglycemic medicine&#xD;
             for 12 months&#xD;
&#xD;
          -  Have diabetic kidney disease and receiving one of two specific medicines used to treat&#xD;
             high blood pressure or diabetic kidney disease for at least 3 months&#xD;
&#xD;
          -  Estimated Glomerular Filtration Rate (eGFR) of 25 to 70 milliliter per minute per 1.73&#xD;
             square meter (mL/min/1.73 m²) (as determined by the Chronic Kidney Disease&#xD;
             Epidemiology Collaboration equation) and a urinary albumin/creatinine ratio (UACR)&#xD;
             &gt;300 milligram per gram (mg/g) and &lt;5000 mg/g&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Too high blood pressure when you enter the study&#xD;
&#xD;
          -  Some specific medicines used to treat high blood pressure or diabetic kidney disease&#xD;
&#xD;
          -  Frequent high blood glucose levels&#xD;
&#xD;
          -  Renal transplant or past history of dialysis&#xD;
&#xD;
          -  Nonsteroidal anti-inflammatory drugs (NSAIDs)&#xD;
&#xD;
          -  Had a special X-ray in the past 30 days which involved also receiving an injection of&#xD;
             dye into the vein&#xD;
&#xD;
          -  Major surgery within 8 weeks of study entry or will require major surgery during the&#xD;
             study&#xD;
&#xD;
          -  Some types of vaccination&#xD;
&#xD;
          -  Shingles or currently have symptoms of a cold sore&#xD;
&#xD;
          -  Serious viral, bacterial, fungal, or parasitic infection, or a urinary infection,&#xD;
             Tuberculosis (TB)&#xD;
&#xD;
          -  Human immunodeficiency virus (HIV) infection- the virus that causes Acquired&#xD;
             immunodeficiency syndrome (AIDS)&#xD;
&#xD;
          -  Have or had some blood disorders, enlarged lymph glands or spleen, or some cancers.&#xD;
&#xD;
          -  Serious circulatory, breathing, liver, stomach or bowel problems, neurological or&#xD;
             psychiatric disorders&#xD;
&#xD;
          -  Heart attack or heart failure, or a stroke&#xD;
&#xD;
          -  Other serious disorders or illnesses&#xD;
&#xD;
          -  Electrocardiogram (ECG) heart trace abnormalities&#xD;
&#xD;
          -  Alcohol or illegal drug abuse&#xD;
&#xD;
          -  Donated more than 500 mL of blood in the last 30 days (no blood donations allowed&#xD;
             during the study)&#xD;
&#xD;
          -  Pregnant or breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)</last_name>
    <role>Study Director</role>
    <affiliation>Eli Lilly and Company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Lancaster</city>
        <state>California</state>
        <zip>93534</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Lakewood</city>
        <state>Colorado</state>
        <zip>80227</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33316</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32258</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33173</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33614</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30909</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96814</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Meridian</city>
        <state>Idaho</state>
        <zip>83642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Gurnee</city>
        <state>Illinois</state>
        <zip>60031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Peoria</city>
        <state>Illinois</state>
        <zip>60603</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Evansville</city>
        <state>Indiana</state>
        <zip>47713</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Topeka</city>
        <state>Kansas</state>
        <zip>66606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Rockville</city>
        <state>Maryland</state>
        <zip>20852</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Pontiac</city>
        <state>Michigan</state>
        <zip>48341</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Springfield</city>
        <state>Missouri</state>
        <zip>65807</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Billings</city>
        <state>Montana</state>
        <zip>59101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Nashua</city>
        <state>New Hampshire</state>
        <zip>03063</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Rosedale</city>
        <state>New York</state>
        <zip>11422</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Bethlehem</city>
        <state>Pennsylvania</state>
        <zip>18017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Sumter</city>
        <state>South Carolina</state>
        <zip>29150</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37408</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Wenatchee</city>
        <state>Washington</state>
        <zip>98801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Fukuoka</city>
        <zip>830-0011</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Hokkaido</city>
        <zip>004-0053</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Ibaragi</city>
        <zip>305-0812</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Ibaraki</city>
        <zip>311-0113</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Osaka</city>
        <zip>530-0001</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Tokyo</city>
        <zip>103-0027</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Merida</city>
        <zip>97070</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Mexico City</city>
        <zip>03300</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Ponce</city>
        <zip>00716</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Rio Piedras</city>
        <zip>00936</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
    <country>Mexico</country>
    <country>Puerto Rico</country>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>September 7, 2012</study_first_submitted>
  <study_first_submitted_qc>September 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2012</study_first_posted>
  <results_first_submitted>March 10, 2017</results_first_submitted>
  <results_first_submitted_qc>June 2, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">July 2, 2017</results_first_posted>
  <disposition_first_submitted>January 16, 2015</disposition_first_submitted>
  <disposition_first_submitted_qc>January 16, 2015</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">January 29, 2015</disposition_first_posted>
  <last_update_submitted>September 10, 2019</last_update_submitted>
  <last_update_submitted_qc>September 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Diabetic Nephropathies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.</ipd_time_frame>
    <ipd_access_criteria>A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.</ipd_access_criteria>
    <ipd_url>https://vivli.org/</ipd_url>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study included a 24-week treatment period and a 4- to 8-week washout period where study drug was discontinued. Time to loss-of-treatment benefit (defined as a failure to maintain a 30% decrease in UACR from baseline) was evaluated at Week 28. Participants who maintained treatment benefit were followed for an additional 4 weeks.</recruitment_details>
      <pre_assignment_details>Participants in each baricitinib dose group were classified by their baseline estimated glomerular filtration rate (eGFR) into higher (50 to 70 milliliter [mL]/minute [min]/1.73 meters squared [m²]) and lower (25 to &lt;50 mL/min/1.73 m²) eGFR strata. Participants in the lower strata had their dose adjusted to a lower dose.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Placebo administered orally (PO) once a day (QD).</description>
        </group>
        <group group_id="P2">
          <title>Baricitinib 0.75 mg/0.5 mg QD</title>
          <description>Baricitinib 0.75 mg or 0.5 mg administered PO QD.</description>
        </group>
        <group group_id="P3">
          <title>Baricitinib 0.75 mg/0.5 mg BID</title>
          <description>Baricitinib 0.75 mg or 0.5 mg administered PO twice a day (BID).</description>
        </group>
        <group group_id="P4">
          <title>Baricitinib 1.5 mg/1 mg</title>
          <description>Baricitinib 1.5 mg or 1 mg administered PO QD.</description>
        </group>
        <group group_id="P5">
          <title>Baricitinib 4 mg/2.75 mg</title>
          <description>Baricitinib 4 milligram (mg) or 2.75 mg administered PO QD.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Treatment Period (Weeks 1-24)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="25"/>
                <participants group_id="P3" count="27"/>
                <participants group_id="P4" count="26"/>
                <participants group_id="P5" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least One Dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="25"/>
                <participants group_id="P3" count="26"/>
                <participants group_id="P4" count="26"/>
                <participants group_id="P5" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="21"/>
                <participants group_id="P3" count="26"/>
                <participants group_id="P4" count="24"/>
                <participants group_id="P5" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Inappropriately Enrolled</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="0"/>
                <participants group_id="P5" 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="3"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
              </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="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</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="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Washout Period 1 (Weeks 25-28)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="21"/>
                <participants group_id="P3" count="26"/>
                <participants group_id="P4" count="24"/>
                <participants group_id="P5" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="17"/>
                <participants group_id="P3" count="25"/>
                <participants group_id="P4" count="22"/>
                <participants group_id="P5" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <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="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Washout Period 2 (Weeks 29-32)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6">Study was completed at Week 28 for 18 participants.</participants>
                <participants group_id="P2" count="6">Study was completed at Week 28 for 11 participants.</participants>
                <participants group_id="P3" count="8">Study was completed at Week 28 for 17 participants.</participants>
                <participants group_id="P4" count="6">Study was completed at Week 28 for 16 participants.</participants>
                <participants group_id="P5" count="12">Study was completed at Week 28 for 8 participants.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</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="0"/>
                <participants group_id="P5" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="3"/>
              </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="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All participants that received at least one dose of study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Placebo administered PO QD.</description>
        </group>
        <group group_id="B2">
          <title>Baricitinib 0.75/0.5 mg QD</title>
          <description>Baricitinib 0.75 mg or 0.5 mg administered PO QD.</description>
        </group>
        <group group_id="B3">
          <title>Baricitinib 0.75 mg/0.5 mg BID</title>
          <description>Baricitinib 0.75 mg or 0.5 mg administered PO BID.</description>
        </group>
        <group group_id="B4">
          <title>Baricitinib 1.5 mg/1 mg QD</title>
          <description>Baricitinib 1.5 mg or 1 mg administered PO QD.</description>
        </group>
        <group group_id="B5">
          <title>Baricitinib 4 mg/2.75 mg</title>
          <description>Baricitinib 4 mg or 2.75 administered PO QD.</description>
        </group>
        <group group_id="B6">
          <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="27"/>
            <count group_id="B2" value="25"/>
            <count group_id="B3" value="26"/>
            <count group_id="B4" value="26"/>
            <count group_id="B5" value="25"/>
            <count group_id="B6" value="129"/>
          </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="64" spread="9.0"/>
                    <measurement group_id="B2" value="61" spread="10.0"/>
                    <measurement group_id="B3" value="64" spread="8.3"/>
                    <measurement group_id="B4" value="61" spread="10.4"/>
                    <measurement group_id="B5" value="63" spread="7.8"/>
                    <measurement group_id="B6" value="63" spread="9.1"/>
                  </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="7"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="10"/>
                    <measurement group_id="B6" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="21"/>
                    <measurement group_id="B4" value="21"/>
                    <measurement group_id="B5" value="15"/>
                    <measurement group_id="B6" value="94"/>
                  </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="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="19"/>
                    <measurement group_id="B5" value="21"/>
                    <measurement group_id="B6" value="104"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </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="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="11"/>
                    <measurement group_id="B5" value="11"/>
                    <measurement group_id="B6" value="60"/>
                  </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="1"/>
                    <measurement group_id="B6" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="13"/>
                    <measurement group_id="B5" value="9"/>
                    <measurement group_id="B6" value="43"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <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="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Puerto Rico</title>
              <category_list>
                <category>
                  <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="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="14"/>
                    <measurement group_id="B5" value="13"/>
                    <measurement group_id="B6" value="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Japan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="11"/>
                    <measurement group_id="B6" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mexico</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Urinary Albumin/Creatinine Ratio (UACR) at Week 24</title>
        <description>UACR is a potential marker of chronic kidney disease, calculated as a ratio of Urinary Albumin and Urinary Creatinine. The least squares mean (LS mean) are from mixed model repeated measures (MMRM) analyses which include treatment, baseline estimated Glomerular Filtration Rate (eGFR) group (higher: 50 to 70 mL/min/1.73m² and lower: 25 to &lt;50 mL/min/1.73m²), visit, treatment-by-visit interaction, baseline UACR, and baseline UACR-by-visit interaction.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>All randomized participants who received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo administered PO QD.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib 0.75 mg/0.5 mg QD</title>
            <description>Baricitinib 0.75 mg or 0.5 mg administered PO QD.</description>
          </group>
          <group group_id="O3">
            <title>Baricitinib 0.75 mg/0.5 mg BID</title>
            <description>Baricitinib 0.75 mg or 0.5 mg administered PO BID.</description>
          </group>
          <group group_id="O4">
            <title>Baricitinib 1.5 mg/1 mg</title>
            <description>Baricitinib 1.5 mg or 1 mg administered PO QD.</description>
          </group>
          <group group_id="O5">
            <title>Baricitinib 4 mg/2.75 mg</title>
            <description>Baricitinib 4 mg or 2.75 mg administered PO QD.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Urinary Albumin/Creatinine Ratio (UACR) at Week 24</title>
          <description>UACR is a potential marker of chronic kidney disease, calculated as a ratio of Urinary Albumin and Urinary Creatinine. The least squares mean (LS mean) are from mixed model repeated measures (MMRM) analyses which include treatment, baseline estimated Glomerular Filtration Rate (eGFR) group (higher: 50 to 70 mL/min/1.73m² and lower: 25 to &lt;50 mL/min/1.73m²), visit, treatment-by-visit interaction, baseline UACR, and baseline UACR-by-visit interaction.</description>
          <population>All randomized participants who received at least one dose of study drug.</population>
          <units>milligram/gram (mg/g)</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="26"/>
                <count group_id="O4" value="26"/>
                <count group_id="O5" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.12" spread="0.172"/>
                    <measurement group_id="O2" value="0.87" spread="0.155"/>
                    <measurement group_id="O3" value="0.85" spread="0.131"/>
                    <measurement group_id="O4" value="0.91" spread="0.143"/>
                    <measurement group_id="O5" value="0.66" spread="0.111"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Urinary Monocyte Chemotactic Protein 1 (MCP-1)/Creatinine Ratio</title>
        <time_frame>Baseline, Week 24</time_frame>
        <population>Zero participants analyzed. No data analyzed due to urinary MCP-1 and creatinine being measured on different urine samples from different time points and thus not able to correlate.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo administered PO QD.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib 0.75 mg/0.5 mg QD</title>
            <description>Baricitinib 0.75 mg or 0.5 mg administered PO QD.</description>
          </group>
          <group group_id="O3">
            <title>Baricitinib 0.75 mg/0.5 mg BID</title>
            <description>Baricitinib 0.75 mg or 0.5 mg administered PO BID.</description>
          </group>
          <group group_id="O4">
            <title>Baricitinib 1.5 mg/1 mg</title>
            <description>Baricitinib 1.5 mg or 1 mg administered PO QD.</description>
          </group>
          <group group_id="O5">
            <title>Baricitinib 4 mg/2.75 mg</title>
            <description>Baricitinib 4 mg or 2.75 mg administered PO QD.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Urinary Monocyte Chemotactic Protein 1 (MCP-1)/Creatinine Ratio</title>
          <population>Zero participants analyzed. No data analyzed due to urinary MCP-1 and creatinine being measured on different urine samples from different time points and thus not able to correlate.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Creatinine Clearance at Week 24</title>
        <description>Creatinine clearance is the amount of creatinine cleared from kidney within 24 hours. The LS mean was from MMRM analyses which included treatment, baseline eGRF group, visit, treatment-by-visit interaction, baseline Creatinine Clearance, and baseline Creatinine Clearance-by-visit interaction.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>All randomized participants who received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo administered PO QD.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib 0.75 mg/0.5 mg QD</title>
            <description>Baricitinib 0.75 mg or 0.5 mg administered PO QD.</description>
          </group>
          <group group_id="O3">
            <title>Baricitinib 0.75 mg/0.5 mg BID</title>
            <description>Baricitinib 0.75 mg or 0.5 mg administered PO BID.</description>
          </group>
          <group group_id="O4">
            <title>Baricitinib 1.5 mg/1 mg</title>
            <description>Baricitinib 1.5 mg or 1 mg administered PO QD.</description>
          </group>
          <group group_id="O5">
            <title>Baricitinib 4 mg/2.75 mg</title>
            <description>Baricitinib 4 mg or 2.75 mg administered PO QD.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Creatinine Clearance at Week 24</title>
          <description>Creatinine clearance is the amount of creatinine cleared from kidney within 24 hours. The LS mean was from MMRM analyses which included treatment, baseline eGRF group, visit, treatment-by-visit interaction, baseline Creatinine Clearance, and baseline Creatinine Clearance-by-visit interaction.</description>
          <population>All randomized participants who received at least one dose of study drug.</population>
          <units>milliliter/minute (mL/min)</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="26"/>
                <count group_id="O4" value="26"/>
                <count group_id="O5" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.93" spread="0.070"/>
                    <measurement group_id="O2" value="1.09" spread="0.104"/>
                    <measurement group_id="O3" value="0.86" spread="0.069"/>
                    <measurement group_id="O4" value="0.86" spread="0.069"/>
                    <measurement group_id="O5" value="0.080" spread="0.066"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) at Week 24</title>
        <description>EQ-5D-5L is a 2-part measurement. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state. The second part is assessed using a visual analog scale (VAS) that ranged from 0 to 100mm, where 0 is the worst health you can imagine and 100 is the best health you can imagine. The LS means are analyzed using an analysis of covariance (ANCOVA) model with treatment, baseline eGFR group, and baseline VAS score or baseline health state index score as covariates.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>All randomized participants who received at least one dose of study drug. Missing values were imputed with the last observation carried forward (LOCF) method.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo administered PO QD.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib 0.75 mg/0.5 mg QD</title>
            <description>Baricitinib 0.75 mg or 0.5 mg administered PO QD.</description>
          </group>
          <group group_id="O3">
            <title>Baricitinib 0.75 mg/0.5 mg BID</title>
            <description>Baricitinib 0.75 mg or 0.5 mg administered PO BID.</description>
          </group>
          <group group_id="O4">
            <title>Baricitinib 1.5 mg/1 mg</title>
            <description>Baricitinib 1.5 mg or 1 mg administered PO QD.</description>
          </group>
          <group group_id="O5">
            <title>Baricitinib 4 mg/2.75 mg</title>
            <description>Baricitinib 4 mg or 2.75 mg administered PO QD.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) at Week 24</title>
          <description>EQ-5D-5L is a 2-part measurement. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state. The second part is assessed using a visual analog scale (VAS) that ranged from 0 to 100mm, where 0 is the worst health you can imagine and 100 is the best health you can imagine. The LS means are analyzed using an analysis of covariance (ANCOVA) model with treatment, baseline eGFR group, and baseline VAS score or baseline health state index score as covariates.</description>
          <population>All randomized participants who received at least one dose of study drug. Missing values were imputed with the last observation carried forward (LOCF) method.</population>
          <units>Units on a Scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="26"/>
                <count group_id="O4" value="26"/>
                <count group_id="O5" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Index Score (UK Algorithm) Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.03"/>
                    <measurement group_id="O2" value="-0.03" spread="0.03"/>
                    <measurement group_id="O3" value="-0.01" spread="0.03"/>
                    <measurement group_id="O4" value="-0.04" spread="0.03"/>
                    <measurement group_id="O5" value="0.00" spread="0.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Index Score (US Algorithm) Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.02"/>
                    <measurement group_id="O2" value="-0.03" spread="0.02"/>
                    <measurement group_id="O3" value="0.00" spread="0.02"/>
                    <measurement group_id="O4" value="-0.03" spread="0.02"/>
                    <measurement group_id="O5" value="0.00" spread="0.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Self-Perceived Health Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.62" spread="2.94"/>
                    <measurement group_id="O2" value="-1.97" spread="3.02"/>
                    <measurement group_id="O3" value="0.28" spread="2.95"/>
                    <measurement group_id="O4" value="-5.66" spread="2.96"/>
                    <measurement group_id="O5" value="0.37" spread="3.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics (PK): Area Under the Concentration-Time Curve at Steady State (AUC,ss)</title>
        <description>Evaluable pharmacokinetic concentrations from the 2-week, 4-week, 8-week, 12-week, 16-week, 20-week and 24-week time points were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state.</description>
        <time_frame>Weeks 2 and 4 (1-2 hours postdose), 8 (3-6 hours postdose), 12 (in fasted state), 16 and 20 (6-9 hours postdose), 24 (in fasted state)</time_frame>
        <population>All randomized participants who received at least one dose of study drug and had evaluable PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>Baricitinib 0.75 mg/0.5 mg QD</title>
            <description>Baricitinib 0.75 mg or 0.5 mg administered PO QD.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib 0.75 mg/0.5 mg BID</title>
            <description>Baricitinib 0.75 mg or 0.5 mg administered PO BID.</description>
          </group>
          <group group_id="O3">
            <title>Baricitinib 1.5 mg/1 mg</title>
            <description>Baricitinib 1.5 mg or 1 mg administered PO QD.</description>
          </group>
          <group group_id="O4">
            <title>Baricitinib 4 mg/2.75 mg</title>
            <description>Baricitinib 4 mg or 2.75 mg administered PO QD.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK): Area Under the Concentration-Time Curve at Steady State (AUC,ss)</title>
          <description>Evaluable pharmacokinetic concentrations from the 2-week, 4-week, 8-week, 12-week, 16-week, 20-week and 24-week time points were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state.</description>
          <population>All randomized participants who received at least one dose of study drug and had evaluable PK data.</population>
          <units>nanomole*hour (nM*hr)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="26"/>
                <count group_id="O3" value="26"/>
                <count group_id="O4" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="198" spread="89.9"/>
                    <measurement group_id="O2" value="286" spread="92.4"/>
                    <measurement group_id="O3" value="388" spread="151"/>
                    <measurement group_id="O4" value="1250" spread="577"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Placebo administered PO QD.</description>
        </group>
        <group group_id="E2">
          <title>Baricitinib 0.75 mg/0.5 mg QD</title>
          <description>Baricitinib 0.75 mg or 0.5 mg administered PO QD.</description>
        </group>
        <group group_id="E3">
          <title>Baricitinib 0.75 mg/0.5 mg BID</title>
          <description>Baricitinib 0.75 mg or 0.5 mg administered PO BID.</description>
        </group>
        <group group_id="E4">
          <title>Baricitinib 1.5 mg/1 mg</title>
          <description>Baricitinib 1.5 mg or 1 mg administered PO QD.</description>
        </group>
        <group group_id="E5">
          <title>Baricitinib 4 mg/2.75 mg</title>
          <description>Baricitinib 4 mg or 2.75 mg administered PO QD.</description>
        </group>
        <group group_id="E6">
          <title>Placebo - Washout 1</title>
          <description>Placebo administered PO QD.</description>
        </group>
        <group group_id="E7">
          <title>Baricitinib 0.75 mg/0.5 mg QD - Washout 1</title>
          <description>Baricitinib 0.75 mg or 0.5 mg administered PO QD.</description>
        </group>
        <group group_id="E8">
          <title>Baricitinib 0.75 mg/0.5 mg BID - Washout 1</title>
          <description>Baricitinib 0.75 mg or 0.5 mg administered PO BID.</description>
        </group>
        <group group_id="E9">
          <title>Baricitinib 1.5 mg/1 mg - Washout 1</title>
          <description>Baricitinib 1.5 mg or 1 mg administered PO QD.</description>
        </group>
        <group group_id="E10">
          <title>Baricitinib 4 mg/2.75 mg - Washout 1</title>
          <description>Baricitinib 4 mg or 2.75 mg administered PO QD.</description>
        </group>
        <group group_id="E11">
          <title>Placebo Washout 2</title>
          <description>Placebo administered PO QD.</description>
        </group>
        <group group_id="E12">
          <title>Baricitinib 0.75 mg/0.5 mg QD - Washout 2</title>
          <description>Baricitinib 0.75 mg or 0.5 mg administered PO QD.</description>
        </group>
        <group group_id="E13">
          <title>Baricitinib 0.75 mg/0.5 mg BID - Washout 2</title>
          <description>Baricitinib 0.75 mg or 0.5 mg administered PO BID.</description>
        </group>
        <group group_id="E14">
          <title>Baricitinib 1.5 mg/1 mg - Washout 2</title>
          <description>Baricitinib 1.5 mg or 1 mg administered PO QD.</description>
        </group>
        <group group_id="E15">
          <title>Baricitinib 4 mg/2.75 mg - Washout 2</title>
          <description>Baricitinib 4 mg or 2.75 mg administered PO QD.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 16.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic valve incompetence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 16.1">Atrial fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Mitral valve incompetence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 16.1">Pericardial effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Vitreous haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title vocab="MedDRA 16.1">Pancreatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaphylactic reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 16.1">Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Staphylococcal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title vocab="MedDRA 16.1">Renal failure acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title vocab="MedDRA 16.1">Respiratory failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 16.0</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="18" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="17" subjects_at_risk="26"/>
                <counts group_id="E4" subjects_affected="19" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="23" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="7" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="8" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="3" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title vocab="MedDRA 16.1">Anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E5" events="7" subjects_affected="7" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Haemolytic anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Nephrogenic anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title vocab="MedDRA 16.1">Angina unstable</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Bundle branch block left</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Cardiac hypertrophy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Cardiomegaly</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Cerumen impaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 16.1">Ear pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 16.1">Vertigo</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperparathyroidism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Abnormal sensation in eye</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Diabetic retinopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Eye pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Visual acuity reduced</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title vocab="MedDRA 16.1">Abdominal pain upper</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Diabetic gastroparesis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 16.1">Diarrhoea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Diverticulum</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Diverticulum intestinal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Epigastric discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Food poisoning</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Gastric polyps</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Large intestine polyp</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E5" events="4" subjects_affected="3" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Oesophageal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 16.1">Reflux gastritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Umbilical hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 17.0">Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 17.0">Injection site nodule</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 16.1">Oedema peripheral</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Thirst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title vocab="MedDRA 16.1">Hepatic steatosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Drug hypersensitivity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Food allergy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title vocab="MedDRA 16.1">Bronchitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 16.1">Gastroenteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 16.1">Helicobacter infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Infection parasitic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 17.0">Localised infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 16.1">Nasopharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" events="6" subjects_affected="4" subjects_at_risk="25"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="26"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="26"/>
                <counts group_id="E5" events="4" subjects_affected="3" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Otitis externa</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 16.1">Otitis media</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" events="2" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 16.1">Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 17.0">Pyelonephritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 17.0">Respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 16.1">Sinusitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 16.1">Tinea pedis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Tooth abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 16.1">Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Urethritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arthropod bite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Meniscus injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 16.1">Muscle strain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 17.0">Wound secretion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title vocab="MedDRA 16.1">Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="4" subjects_affected="3" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Glycosylated haemoglobin increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Haematocrit decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Haemoglobin decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Heart rate decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Occult blood</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 17.0">Occult blood positive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Red blood cell count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 16.1">Vitamin D decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>White blood cells urine positive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title vocab="MedDRA 16.1">Dehydration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 17.0">Diabetes mellitus inadequate control</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 15.1">Hypercalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 17.0">Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 16.1">Hyperkalaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Hyperlipidaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Hyperuricaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 17.0">Hypoglycaemia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 17.0">Iron deficiency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Metabolic acidosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title vocab="MedDRA 16.1">Arthralgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 16.1">Back pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 17.0">Bursitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Exostosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Joint swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 16.1">Muscle spasms</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="26"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 17.0">Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 16.1">Musculoskeletal stiffness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 17.0">Osteoarthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Osteochondritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="3" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Sensation of heaviness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 16.1">Dizziness</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 16.1">Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 16.1">Head banging</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Azotaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 17.0">Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 16.1">Pollakiuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Renal failure acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 16.1">Renal impairment</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 17.0">Dyspnoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 16.1">Dyspnoea exertional</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 16.1">Lung infiltration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 16.1">Oropharyngeal discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Respiratory tract congestion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 16.1">Rhinitis allergic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Sinus congestion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Sinus disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Sneezing</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract inflammation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic bullosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Ingrowing nail</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Panniculitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 17.0">Pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 16.1">Rash</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Skin lesion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Xeroderma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Cataract operation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Tooth extraction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title vocab="MedDRA 17.0">Hot flush</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title vocab="MedDRA 16.1">Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Microscopic polyangiitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Peripheral vascular disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Chief Medical Officer</name_or_title>
      <organization>Eli Lilly and Company</organization>
      <phone>800-545-5979</phone>
    </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/NCT01683409
org study id: 14734
secondary id: I4V-MC-JAGQ
nct id: NCT01683409
lead sponsor: 
collaborator: 
has dmc: No
This is a dose ranging study to evaluate the safety and efficacy of baricitinib in the
      treatment of participants with mild to moderate diabetic kidney disease.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change From Baseline in Urinary Albumin/Creatinine Ratio (UACR) at Week 24
time frame: Baseline, Week 24
description: UACR is a potential marker of chronic kidney disease, calculated as a ratio of Urinary Albumin and Urinary Creatinine. The least squares mean (LS mean) are from mixed model repeated measures (MMRM) analyses which include treatment, baseline estimated Glomerular Filtration Rate (eGFR) group (higher: 50 to 70 mL/min/1.73m² and lower: 25 to <50 mL/min/1.73m²), visit, treatment-by-visit interaction, baseline UACR, and baseline UACR-by-visit interaction.
measure: Change From Baseline in Urinary Monocyte Chemotactic Protein 1 (MCP-1)/Creatinine Ratio
time frame: Baseline, Week 24
measure: Change From Baseline in Creatinine Clearance at Week 24
time frame: Baseline, Week 24
description: Creatinine clearance is the amount of creatinine cleared from kidney within 24 hours. The LS mean was from MMRM analyses which included treatment, baseline eGRF group, visit, treatment-by-visit interaction, baseline Creatinine Clearance, and baseline Creatinine Clearance-by-visit interaction.
measure: Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) at Week 24
time frame: Baseline, Week 24
description: EQ-5D-5L is a 2-part measurement. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state. The second part is assessed using a visual analog scale (VAS) that ranged from 0 to 100mm, where 0 is the worst health you can imagine and 100 is the best health you can imagine. The LS means are analyzed using an analysis of covariance (ANCOVA) model with treatment, baseline eGFR group, and baseline VAS score or baseline health state index score as covariates.
measure: Pharmacokinetics (PK): Area Under the Concentration-Time Curve at Steady State (AUC,ss)
time frame: Weeks 2 and 4 (1-2 hours postdose), 8 (3-6 hours postdose), 12 (in fasted state), 16 and 20 (6-9 hours postdose), 24 (in fasted state)
description: Evaluable pharmacokinetic concentrations from the 2-week, 4-week, 8-week, 12-week, 16-week, 20-week and 24-week time points were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state.
arm group label: Placebo
arm group type: Placebo Comparator
description: Administered orally, given as three placebo tablets in the morning and one placebo tablet in the evening for 24 weeks.
arm group label: Baricitinib 0.75 mg/0.5 mg QD
arm group type: Experimental
description: Administered orally, 0.75 mg given as one 0.75 mg tablets and two placebo tablets in the morning and one placebo tablet in the evening for 24 weeks or 0.5 mg given as one 0.5 mg tablet and two placebo tablets in the morning and one placebo tablet in the evening for 24 weeks. Placebo tablets given to maintain blind.
arm group label: Baricitinib 0.75 mg/0.5 mg BID
arm group type: Experimental
description: Administered orally, 0.75 mg given as one 0.75 tablet and 2 placebo in the morning and one 0.75 mg tablet in the evening for 24 weeks or 0.5 mg given as one 0.5 mg tablet and two placebo tablets in the morning and one 0.5 mg tablet in the evening. Placebo tablets given to maintain blind.
arm group label: Baricitinib 1.5 mg/1 mg
arm group type: Experimental
description: Administered orally, 1.5 mg given as two 0.75 mg tablets and 1 placebo tablet in the morning and one placebo tablet in the evening for 24 weeks or 1 mg tablet and two placebo tablets in the morning and one placebo tablet in the evening for 24 weeks. Placebo tablets given to maintain blind.
arm group label: Baricitinib 4 mg/2.75 mg
arm group type: Experimental
description: Administered orally, 4 mg given as one tablet and 2 placebo tablets in the morning and one placebo tablet in the evening for 24 weeks or 2.75 mg given as two 1 mg tablets and one 0.75 mg tablet in the morning and one placebo tablet in the evening for 24 weeks. Placebo tablets given to maintain blind.
intervention type: Drug
intervention name: Baricitinib
description: Administered orally
arm group label: Baricitinib 0.75 mg/0.5 mg BID
arm group label: Baricitinib 0.75 mg/0.5 mg QD
arm group label: Baricitinib 1.5 mg/1 mg
arm group label: Baricitinib 4 mg/2.75 mg
other name: LY3009104
other name: INCB28050
intervention type: Drug
intervention name: Placebo
description: Administered orally
arm group label: Baricitinib 0.75 mg/0.5 mg BID
arm group label: Baricitinib 0.75 mg/0.5 mg QD
arm group label: Baricitinib 1.5 mg/1 mg
arm group label: Baricitinib 4 mg/2.75 mg
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: Study Director
affiliation: Eli Lilly and Company
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country: Japan
country: Mexico
country: Puerto Rico
country: United States
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Diabetic Nephropathies
sharing ipd: Yes
ipd description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
ipd access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
ipd url: https://vivli.org/
participant flow: 
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outcome list: 
reported events: 
certain agreements: 
point of contact: 