<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/NCT01720446</url>
  </required_header>
  <id_info>
    <org_study_id>NN9535-3744</org_study_id>
    <secondary_id>2012-002839-28</secondary_id>
    <secondary_id>U1111-1131-7227</secondary_id>
    <nct_id>NCT01720446</nct_id>
  </id_info>
  <brief_title>Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes</brief_title>
  <acronym>SUSTAIN™ 6</acronym>
  <official_title>A Long-term, Randomised, Double-blind, Placebo-controlled, Multinational, Multi-centre Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes (SUSTAIN™ 6 - Long-term Outcomes)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novo Nordisk A/S</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novo Nordisk A/S</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial is conducted globally. The aim of the trial is to evaluate cardiovascular and&#xD;
      other long-term outcomes with semaglutide in subjects with type 2 diabetes. The trial is&#xD;
      event-driven, i.e. the maximum trial duration (up to max. 148 weeks) will depend on the&#xD;
      accrual of major adverse cardiovascular events (MACE) in this trial and the remaining&#xD;
      research programme. The incidence of MACE will be monitored throughout the trial which will&#xD;
      be terminated according to plan when pre-specified stopping criteria are met.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 21, 2013</start_date>
  <completion_date type="Actual">March 15, 2016</completion_date>
  <primary_completion_date type="Actual">March 15, 2016</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time From Randomisation to First Occurrence of a MACE, Defined as Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke</measure>
    <time_frame>Time from randomisation up to end of follow-up (scheduled at week 109)</time_frame>
    <description>Percentage of subjects experiencing a first event of a major adverse cardiovascular event (MACE), defined as cardiovascular (CV) death, non-fatal myocardial infarction (MI), or non-fatal stroke.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time From Randomisation to First Occurrence of an Expanded Composite Cardiovascular Outcome</measure>
    <time_frame>Time from randomisation up to end of follow-up (scheduled at week 109)</time_frame>
    <description>Percentage of subjects experiencing first occurrence of an expanded composite CV outcome (defined as either MACE, revascularisation [coronary and peripheral], unstable angina requiring hospitalisation or hospitalisation for heart failure)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome</measure>
    <time_frame>Time from randomisation up to end of follow-up (scheduled at week 109)</time_frame>
    <description>Percentage of subjects experiencing an event onset for each individual component of the expanded composite cardiovascular outcomes (defined as either MACE, revascularisation [coronary and peripheral], unstable angina requiring hospitalisation or hospitalisation for heart failure).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time From Randomisation to First Occurrence of All-cause Death, Non-fatal MI, or Non-fatal Stroke</measure>
    <time_frame>Time from randomisation up to end of follow-up (scheduled at week 109)</time_frame>
    <description>Percentage of subjects experiencing a first occurrence of all-cause death, non-fatal MI, or non-fatal stroke.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Glycosylated Haemoglobin (HbA1c)</measure>
    <time_frame>Week 0, up to week 104</time_frame>
    <description>Estimated mean change from baseline in glycosylated haemoglobin (HbA1c) to last assessment in the trial during the treatment period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Fasting Plasma Glucose</measure>
    <time_frame>Week 0, up to week 104</time_frame>
    <description>Estimated mean change from baseline to last assessment in fasting plasma glucose in the trial during the treatment period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Body Weight</measure>
    <time_frame>Week 0, up to week 104</time_frame>
    <description>Estimated mean change from baseline to last assessment in body weight in the trial during the treatment period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Lipid Profile</measure>
    <time_frame>Week 0, up to week 104</time_frame>
    <description>Estimated ratio to baseline at week 104 during the treatment period in lipid profile (total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Urinary Albumin to Creatinine Ratio</measure>
    <time_frame>Week 0, up to week 104</time_frame>
    <description>Estimated ratio to baseline in urinary albumin to creatinine ratio at week 104 during the treatment period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Vital Signs</measure>
    <time_frame>Week 0, up to week 104</time_frame>
    <description>Estimated mean change from baseline to last assessment in the trial during the treatment period in vital signs (diastolic blood pressure and systolic blood pressure).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence During the Trial in Other Treatment Outcomes: Hypoglycaemic Events</measure>
    <time_frame>Week 0 - 109</time_frame>
    <description>Rates (event rate per 100 exposure years) of severe or blood glucose confirmed symptomatic hypoglycaemia defned as an episode that was severe according to the American diabetic association (ADA) classification or blood glucose (BG) confirmed by a PG value &lt;3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence During the Trial in Other Treatment Outcomes: Adverse Events</measure>
    <time_frame>Weeks 0-109</time_frame>
    <description>Rates (event rate per 100 years of exposure) of treatment emergent adverse events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence During the Trial in Other Treatment Outcomes: Anti-semaglutide Antibodies</measure>
    <time_frame>Weeks 0-109</time_frame>
    <description>The percentage of subjects that tested positive for anti-semaglutide antibodies at any time point post-baseline during the trial, from week 0 to week 109.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Patient Reported Outcome (PRO)</measure>
    <time_frame>Week 0, up to week 104</time_frame>
    <description>Estimated mean change from baseline to last assessment in the trial in patient reported outcomes (PRO). PRO questionnaire (SF-36v2TM) measured the individual overall health related quality of life namely bodily pain, general health, mental component summary, mental health, physical component summary, physical functioning, role-emotional, role-physical, social functioning and vitality. The PRO scores were transformed to a 0-100 scale with higher scores indicating greater health related quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Lipid Profile (Free Fatty Acids)</measure>
    <time_frame>Week 0, up to week 104</time_frame>
    <description>Estimated ratio to baseline at week 104 during the treatment period in lipid profile (free fatty acids).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Vital Signs (Pulse Rate)</measure>
    <time_frame>Week 0, up to week 104</time_frame>
    <description>Estimated mean change from baseline to last assessment in the trial during the treatment period in vital signs (pulse rate).</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">3297</enrollment>
  <condition>Diabetes</condition>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Semaglutide 0.5 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Semaglutide 1.0 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Semaglutide placebo 0.5 mg</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Semaglutide placebo 1.0 mg</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>semaglutide</intervention_name>
    <description>Once weekly doses of 0.5 mg semaglutide after an initial dose escalation step of 0.25 mg as an add-on to the standard-of-care treatment. Administered subcutaneously (s.c., under the skin)</description>
    <arm_group_label>Semaglutide 0.5 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>semaglutide</intervention_name>
    <description>Once weekly doses of 1.0 mg semaglutide after an initial dose escalation step of 0.25 mg followed by 0.5 mg dose escalation as an add-on to the standard-of-care treatment. Administered subcutaneously (s.c., under the skin)</description>
    <arm_group_label>Semaglutide 1.0 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>Once weekly doses volume-matched placebo, as an add-on to the standard-of-care treatment. Administered subcutaneously (s.c., under the skin).</description>
    <arm_group_label>Semaglutide placebo 0.5 mg</arm_group_label>
    <arm_group_label>Semaglutide placebo 1.0 mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: - Men and women with type 2 diabetes mellitus - Age above or equal to&#xD;
        50 years at screening and clinical evidence of cardiovascular disease or age above or equal&#xD;
        to 60 years at screening and subclinical evidence of cardiovascular disease - Anti-diabetic&#xD;
        drug naïve, or treated with one or two oral antidiabetic drug (OADs), or treated with human&#xD;
        Neutral Protamin Hagedorn (NPH) insulin or long-acting insulin analogue or pre-mixed&#xD;
        insulin, both types of insulin either alone or in combination with one or two OADs - HbA1c&#xD;
        above or equal to 7.0% at screening Exclusion Criteria: - Type 1 diabetes mellitus - Use of&#xD;
        glucagon-like peptide-1 (GLP-1) receptor agonist (exenatide, liraglutide, or other) or&#xD;
        pramlintide within 90 days prior to screening - Use of any dipeptidyl peptidase 4 (DPP-IV)&#xD;
        inhibitor within 30 days prior to screening - Treatment with insulin other than basal and&#xD;
        pre-mixed insulin within 90 days prior to screening - except for short-term use in&#xD;
        connection with intercurrent illness - Acute decompensation of glycaemic control requiring&#xD;
        immediate intensification of treatment to prevent acute complications of diabetes (eg&#xD;
        diabetes ketoacidosis) within 90 days prior to screening - History of chronic pancreatitis&#xD;
        or idiopathic acute pancreatitis - Acute coronary or cerebro-vascular event within 90 days&#xD;
        prior to randomisation - Currently planned coronary, carotid or peripheral artery&#xD;
        revascularisation - Chronic heart failure New York Heart Association (NYHA) class IV -&#xD;
        Personal or family history of multiple endocrine neoplasia type 2 (MEN2) or familial&#xD;
        medullary thyroid carcinoma - Personal history of non-familial medullary thyroid carcinoma&#xD;
        - Screening calcitonin above or equal to 50 ng/L&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Global Clinical Registry (GCR, 1452)</last_name>
    <role>Study Director</role>
    <affiliation>Novo Nordisk A/S</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35205-4731</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chandler</city>
        <state>Arizona</state>
        <zip>85224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Greenbrae</city>
        <state>California</state>
        <zip>94904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Lancaster</city>
        <state>California</state>
        <zip>93534</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90017-4006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Mission Hills</city>
        <state>California</state>
        <zip>91345</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Monterey</city>
        <state>California</state>
        <zip>93940</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Northridge</city>
        <state>California</state>
        <zip>91325</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>San Ramon</city>
        <state>California</state>
        <zip>94583</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Ventura</city>
        <state>California</state>
        <zip>93003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Waterbury</city>
        <state>Connecticut</state>
        <zip>06708</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Bradenton</city>
        <state>Florida</state>
        <zip>34201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Crystal River</city>
        <state>Florida</state>
        <zip>34429</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>DeLand</city>
        <state>Florida</state>
        <zip>32724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Melbourne</city>
        <state>Florida</state>
        <zip>32901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Melbourne</city>
        <state>Florida</state>
        <zip>32934</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Ocala</city>
        <state>Florida</state>
        <zip>34470</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Ponte Vedra</city>
        <state>Florida</state>
        <zip>32081</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33707</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Spring Hill</city>
        <state>Florida</state>
        <zip>34609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Dunwoody</city>
        <state>Georgia</state>
        <zip>30338</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Lawrenceville</city>
        <state>Georgia</state>
        <zip>30046</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Crystal Lake</city>
        <state>Illinois</state>
        <zip>60012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Gurnee</city>
        <state>Illinois</state>
        <zip>60031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Michigan City</city>
        <state>Indiana</state>
        <zip>46360</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Mishawaka</city>
        <state>Indiana</state>
        <zip>46544</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Monroe</city>
        <state>Louisiana</state>
        <zip>71203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Methuen</city>
        <state>Massachusetts</state>
        <zip>01844</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>North Dartmouth</city>
        <state>Massachusetts</state>
        <zip>02747</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kalamazoo</city>
        <state>Michigan</state>
        <zip>49048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chesterfield</city>
        <state>Missouri</state>
        <zip>63017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68198-3020</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Nashua</city>
        <state>New Hampshire</state>
        <zip>03063</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Mine Hill</city>
        <state>New Jersey</state>
        <zip>07803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Toms River</city>
        <state>New Jersey</state>
        <zip>08755-8050</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Staten Island</city>
        <state>New York</state>
        <zip>10301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>West Seneca</city>
        <state>New York</state>
        <zip>14224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Asheboro</city>
        <state>North Carolina</state>
        <zip>27203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <zip>28801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27517</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Greenville</city>
        <state>North Carolina</state>
        <zip>27834</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Whiteville</city>
        <state>North Carolina</state>
        <zip>28472</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Wilmington</city>
        <state>North Carolina</state>
        <zip>28401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Franklin</city>
        <state>Ohio</state>
        <zip>45005</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Mason</city>
        <state>Ohio</state>
        <zip>45040-6815</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Maumee</city>
        <state>Ohio</state>
        <zip>43537</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Beaver</city>
        <state>Pennsylvania</state>
        <zip>15009-1957</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>McMurray</city>
        <state>Pennsylvania</state>
        <zip>15317</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Greer</city>
        <state>South Carolina</state>
        <zip>29651</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Myrtle Beach</city>
        <state>South Carolina</state>
        <zip>29572</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Bartlett</city>
        <state>Tennessee</state>
        <zip>38133</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kingsport</city>
        <state>Tennessee</state>
        <zip>37660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38163</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390-9302</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77074</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Irving</city>
        <state>Texas</state>
        <zip>75061-2210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Longview</city>
        <state>Texas</state>
        <zip>75605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Odessa</city>
        <state>Texas</state>
        <zip>79761</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75075</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78228-3419</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Sugar Land</city>
        <state>Texas</state>
        <zip>77478</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>South Burlington</city>
        <state>Vermont</state>
        <zip>05403-7205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Winchester</city>
        <state>Virginia</state>
        <zip>22601-3834</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Winchester</city>
        <state>Virginia</state>
        <zip>22601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Wenatchee</city>
        <state>Washington</state>
        <zip>98801-2028</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Annaba</city>
        <zip>23000</zip>
        <country>Algeria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Oran</city>
        <zip>31000</zip>
        <country>Algeria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Setif</city>
        <zip>19000</zip>
        <country>Algeria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tizi Ouzou</city>
        <zip>15000</zip>
        <country>Algeria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Caba</city>
        <zip>C1093AAS</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Caba</city>
        <zip>C1180AAX</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Caba</city>
        <zip>C1440AAD</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Caba</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Cordoba</city>
        <zip>5000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Mar del Plata</city>
        <zip>B7600FZN</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Morón</city>
        <zip>B1708IFF</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Blacktown</city>
        <state>New South Wales</state>
        <zip>2148</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>St Leonards</city>
        <state>New South Wales</state>
        <zip>2065</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Ipswich</city>
        <state>Queensland</state>
        <zip>4305</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Keswick</city>
        <state>South Australia</state>
        <zip>5035</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Oaklands Park</city>
        <state>South Australia</state>
        <zip>5046</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Box Hill</city>
        <state>Victoria</state>
        <zip>3128</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Fitzroy</city>
        <state>Victoria</state>
        <zip>3065</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Fremantle</city>
        <state>Western Australia</state>
        <zip>6160</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Curitiba</city>
        <state>Parana</state>
        <zip>80030-110</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Belém</city>
        <state>Para</state>
        <zip>66073-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Campinas</city>
        <state>Sao Paulo</state>
        <zip>13059-740</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>São Paulo</city>
        <state>Sao Paulo</state>
        <zip>01228-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>São Paulo</city>
        <state>Sao Paulo</state>
        <zip>01228-200</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>São Paulo</city>
        <state>Sao Paulo</state>
        <zip>04038-002</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>São Paulo</city>
        <state>Sao Paulo</state>
        <zip>05403-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Porto Alegre</city>
        <zip>90035-170</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Pleven</city>
        <zip>5800</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Sofia</city>
        <zip>1324</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Sofia</city>
        <zip>1606</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Varna</city>
        <zip>9010</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2V 4J2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2E1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3E 3P4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>St. John's</city>
        <state>Newfoundland and Labrador</state>
        <zip>A1E 2C2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Cambridge</city>
        <state>Ontario</state>
        <zip>N1R 7L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Cornwall</city>
        <state>Ontario</state>
        <zip>K6H 4M4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 4V2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Smiths Falls</city>
        <state>Ontario</state>
        <zip>K7A 4W8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5C 2T2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Waterloo</city>
        <state>Ontario</state>
        <zip>N2J 1C4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Drummondville</city>
        <state>Quebec</state>
        <zip>J2B 7T1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4A 3T2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Victoriaville</city>
        <state>Quebec</state>
        <zip>G6P 6P6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Quebec</city>
        <zip>G1V 4G5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Aarhus C</city>
        <zip>8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Gentofte</city>
        <zip>2820</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Hellerup</city>
        <zip>2900</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Hvidovre</city>
        <zip>2650</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Odense</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Elsterwerda</city>
        <zip>04910</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Essen</city>
        <zip>45219</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Falkensee</city>
        <zip>14612</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Freiburg</city>
        <zip>79106</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Hamburg</city>
        <zip>22607</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Münster</city>
        <zip>48145</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Oldenburg</city>
        <zip>23758</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Saint Ingbert</city>
        <zip>66386</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Hyderabad</city>
        <state>Andhra Pradesh</state>
        <zip>500003</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Hyderabad</city>
        <state>Andhra Pradesh</state>
        <zip>500034</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Hyderabad</city>
        <state>Andhra Pradesh</state>
        <zip>500082</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Visakhapatnam</city>
        <state>Andhra Pradesh</state>
        <zip>530002</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Bangalore</city>
        <state>Karnataka</state>
        <zip>560034</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Mysore</city>
        <state>Karnataka</state>
        <zip>570001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kochi</city>
        <state>Kerala</state>
        <zip>682041</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Mumbai</city>
        <state>Maharashtra</state>
        <zip>400008</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Mumbai</city>
        <state>Maharashtra</state>
        <zip>400010</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Mumbai</city>
        <state>Maharashtra</state>
        <zip>400012</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Mumbai</city>
        <state>Maharashtra</state>
        <zip>400016</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Mumbai</city>
        <state>Maharashtra</state>
        <zip>400022</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Delhi</city>
        <state>New Delhi</state>
        <zip>110002</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>New Dehli</city>
        <state>New Delhi</state>
        <zip>110029</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chandigarh</city>
        <state>Punjab</state>
        <zip>160012</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chennai</city>
        <state>Tamil Nadu</state>
        <zip>600086</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Vellore</city>
        <state>Tamil Nadu</state>
        <zip>632004</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kolkata</city>
        <state>West Bengal</state>
        <zip>700032</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kolkata</city>
        <state>West Bengal</state>
        <zip>700054</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>New Delhi</city>
        <zip>110095</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Pune</city>
        <zip>411011</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Holon</city>
        <zip>58100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Jerusalem</city>
        <zip>91120</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Nahariya</city>
        <zip>22100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Petah-Tikva</city>
        <zip>49100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tel Hashomer</city>
        <zip>52621</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tel-Aviv</city>
        <zip>64239</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Bergamo</city>
        <zip>24127</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chieti</city>
        <zip>66100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Olbia</city>
        <zip>07026</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Padova</city>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Primo Piano Palazzina Ambulato</city>
        <zip>40133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Siena</city>
        <zip>53100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kota Samarahan</city>
        <zip>94300</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kuala Lumpur</city>
        <zip>59100</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kuching</city>
        <zip>93586</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Melaka</city>
        <zip>75400</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Serdang</city>
        <zip>43000</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Seremban</city>
        <zip>70300</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Guadalajara</city>
        <state>Jalisco</state>
        <zip>44130</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Guadalajara</city>
        <state>Jalisco</state>
        <zip>44600</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Guadalajara</city>
        <state>Jalisco</state>
        <zip>44670</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Cuernavaca</city>
        <state>Morelos</state>
        <zip>62250</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Mexico City</city>
        <state>México, D.F.</state>
        <zip>03300</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Mexico City</city>
        <state>México, D.F.</state>
        <zip>14000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>México D.F.</city>
        <state>México, D.F.</state>
        <zip>11550</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Ciudad Madero</city>
        <state>Tamaulipas</state>
        <zip>89440</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Aguascalientes</city>
        <zip>20230</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>San Luis Potosi</city>
        <zip>78200</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Bialystok</city>
        <zip>15-445</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Gdansk</city>
        <zip>80-858</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Lublin</city>
        <zip>20-044</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Warszawa</city>
        <zip>01-192</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Zabrze</city>
        <zip>41-800</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Arkhangelsk</city>
        <zip>163001</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Arkhangelsk</city>
        <zip>163045</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Barnaul</city>
        <zip>656045</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kazan</city>
        <zip>420043</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Moscow</city>
        <zip>117997</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Moscow</city>
        <zip>119435</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Novosibirsk</city>
        <zip>630047</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Penza</city>
        <zip>440026</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>199034</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Saratov</city>
        <zip>410031</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Saratov</city>
        <zip>410053</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Smolensk</city>
        <zip>214019</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Yaroslavl</city>
        <zip>150062</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Almería</city>
        <zip>04001</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Antequera</city>
        <zip>29200</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Pozuelo de Alarcon</city>
        <zip>28223</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Sanlúcar De Barrameda - Cádiz-</city>
        <zip>15540</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Sevilla</city>
        <zip>41010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Vic (Barcelona)</city>
        <zip>08500</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chiayi City</city>
        <zip>600</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tainan city</city>
        <zip>710</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Taipei</city>
        <zip>114</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Taoyuan</city>
        <zip>333</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Bangkok</city>
        <zip>10330</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Bangkok</city>
        <zip>10400</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Bangkok</city>
        <zip>10700</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Ankara</city>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Ankara</city>
        <zip>06110</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Antalya</city>
        <zip>07058</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Canakkale</city>
        <zip>17020</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Denizli</city>
        <zip>20070</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Istanbul</city>
        <zip>34096</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Istanbul</city>
        <zip>34722</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Istanbul</city>
        <zip>34890</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Izmir</city>
        <zip>35340</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kocaeli</city>
        <zip>41380</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Aberdeen</city>
        <zip>AB25 2ZD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Birmingham</city>
        <zip>B9 5SS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Leeds</city>
        <zip>LS25 1AN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Liverpool</city>
        <zip>L9 7AL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Northwood</city>
        <zip>HA6 2RN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Sidcup</city>
        <zip>DA14 6LT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Swansea</city>
        <zip>SA6 6NL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Torquay</city>
        <zip>TQ2 7AA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Algeria</country>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Brazil</country>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>Denmark</country>
    <country>Germany</country>
    <country>India</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Malaysia</country>
    <country>Mexico</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>Thailand</country>
    <country>Turkey</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://novonordisk-trials.com</url>
    <description>Clinical Trials at Novo Nordisk</description>
  </link>
  <reference>
    <citation>Verma S, Bain SC, Monk Fries T, Mazer CD, Nauck MA, Pratley RE, Rasmussen S, Saevereid HA, Zinman B, Buse JB. Duration of diabetes and cardiorenal efficacy of liraglutide and semaglutide: A post hoc analysis of the LEADER and SUSTAIN 6 clinical trials. Diabetes Obes Metab. 2019 Jul;21(7):1745-1751. doi: 10.1111/dom.13698. Epub 2019 Apr 2.</citation>
    <PMID>30851070</PMID>
  </reference>
  <results_reference>
    <citation>Marso SP, Bain SC, Consoli A, Eliaschewitz FG, Jodar E, Leiter LA, Lingvay I, Rosenstock J, Seufert J, Warren ML, Woo V, Hansen O, Holst AG, Pettersson J, Vilsboll T; SUSTAIN-6 Investigators. Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. N Engl J Med. 2016 Nov 10;375(19):1834-1844. doi: 10.1056/NEJMoa1607141. Epub 2016 Sep 15.</citation>
    <PMID>27633186</PMID>
  </results_reference>
  <results_reference>
    <citation>Vilsboll T, Bain SC, Leiter LA, Lingvay I, Matthews D, Simo R, Helmark IC, Wijayasinghe N, Larsen M. Semaglutide, reduction in glycated haemoglobin and the risk of diabetic retinopathy. Diabetes Obes Metab. 2018 Apr;20(4):889-897. doi: 10.1111/dom.13172. Epub 2018 Jan 8.</citation>
    <PMID>29178519</PMID>
  </results_reference>
  <results_reference>
    <citation>Carlsson Petri KC, Ingwersen SH, Flint A, Zacho J, Overgaard RV. Semaglutide s.c. Once-Weekly in Type 2 Diabetes: A Population Pharmacokinetic Analysis. Diabetes Ther. 2018 Aug;9(4):1533-1547. doi: 10.1007/s13300-018-0458-5. Epub 2018 Jun 15.</citation>
    <PMID>29907893</PMID>
  </results_reference>
  <results_reference>
    <citation>Aroda VR, Ahmann A, Cariou B, Chow F, Davies MJ, Jodar E, Mehta R, Woo V, Lingvay I. Comparative efficacy, safety, and cardiovascular outcomes with once-weekly subcutaneous semaglutide in the treatment of type 2 diabetes: Insights from the SUSTAIN 1-7 trials. Diabetes Metab. 2019 Oct;45(5):409-418. doi: 10.1016/j.diabet.2018.12.001. Epub 2019 Jan 4.</citation>
    <PMID>30615985</PMID>
  </results_reference>
  <results_reference>
    <citation>Leiter LA, Bain SC, Hramiak I, Jodar E, Madsbad S, Gondolf T, Hansen T, Holst I, Lingvay I. Cardiovascular risk reduction with once-weekly semaglutide in subjects with type 2 diabetes: a post hoc analysis of gender, age, and baseline CV risk profile in the SUSTAIN 6 trial. Cardiovasc Diabetol. 2019 Jun 6;18(1):73. doi: 10.1186/s12933-019-0871-8.</citation>
    <PMID>31167654</PMID>
  </results_reference>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>October 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 2, 2012</study_first_posted>
  <results_first_submitted>December 14, 2017</results_first_submitted>
  <results_first_submitted_qc>February 15, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">March 15, 2018</results_first_posted>
  <disposition_first_submitted>December 13, 2016</disposition_first_submitted>
  <disposition_first_submitted_qc>December 13, 2016</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">December 14, 2016</disposition_first_posted>
  <last_update_submitted>June 20, 2019</last_update_submitted>
  <last_update_submitted_qc>June 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 27, 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>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The trial was conducted at 229 sites in 20 countries. Country (sites): Algeria (4), Argentina (7), Australia (8), Brazil (8), Bulgaria (5), Canada (13), Denmark (5), Germany (7), Israel (6), Italy (6), Malaysia (6), Mexico (9), Poland (5), Russia (11), Spain (6), Taiwan (4), Thailand (5), Turkey (10), United Kingdom (8) and United States (96).</recruitment_details>
      <pre_assignment_details>Subjects could be anti-glycaemic drug naïve, or treated with 1 or 2 oral anti diabetic drugs (OADs), or treated with human NPH insulin or long-acting insulin analogue or pre-mixed insulin, alone or in combination with 1 or 2 OAD(s).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Semaglutide 0.5 mg</title>
          <description>Subjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.</description>
        </group>
        <group group_id="P2">
          <title>Semaglutide 1.0 mg</title>
          <description>Subjects received once-weekly dose of semaglutide 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.</description>
        </group>
        <group group_id="P3">
          <title>Placebo 0.5 mg</title>
          <description>Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.</description>
        </group>
        <group group_id="P4">
          <title>Placebo 1.0 mg</title>
          <description>Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="826"/>
                <participants group_id="P2" count="822"/>
                <participants group_id="P3" count="824"/>
                <participants group_id="P4" count="825"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Premature Treatment Discontinuers</title>
              <participants_list>
                <participants group_id="P1" count="164">Premature treatment discontinuers were allowed to continue participation in the trial.</participants>
                <participants group_id="P2" count="186">Premature treatment discontinuers were allowed to continue participation in the trial.</participants>
                <participants group_id="P3" count="151">Premature treatment discontinuers were allowed to continue participation in the trial.</participants>
                <participants group_id="P4" count="159">Premature treatment discontinuers were allowed to continue participation in the trial.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="812">Subjects who did not permanently discontinue treatment prematurely.</participants>
                <participants group_id="P2" count="811">Subjects who did not permanently discontinue treatment prematurely.</participants>
                <participants group_id="P3" count="804">Subjects who did not permanently discontinue treatment prematurely.</participants>
                <participants group_id="P4" count="805">Subjects who did not permanently discontinue treatment prematurely.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="11"/>
                <participants group_id="P3" count="20"/>
                <participants group_id="P4" count="20"/>
              </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="12"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="16"/>
                <participants group_id="P4" count="16"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Analysis was performed on full analysis set which included all randomised subjects.</population>
      <group_list>
        <group group_id="B1">
          <title>Semaglutide 0.5 mg</title>
          <description>Subjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.</description>
        </group>
        <group group_id="B2">
          <title>Semaglutide 1.0 mg</title>
          <description>Subjects received once-weekly dose of semaglutide 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.</description>
        </group>
        <group group_id="B3">
          <title>Placebo 0.5 mg</title>
          <description>Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.</description>
        </group>
        <group group_id="B4">
          <title>Placebo 1.0 mg</title>
          <description>Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.</description>
        </group>
        <group group_id="B5">
          <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="826"/>
            <count group_id="B2" value="822"/>
            <count group_id="B3" value="824"/>
            <count group_id="B4" value="825"/>
            <count group_id="B5" value="3297"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>50-64 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="440"/>
                    <measurement group_id="B2" value="415"/>
                    <measurement group_id="B3" value="419"/>
                    <measurement group_id="B4" value="425"/>
                    <measurement group_id="B5" value="1699"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>65-74 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="312"/>
                    <measurement group_id="B2" value="324"/>
                    <measurement group_id="B3" value="324"/>
                    <measurement group_id="B4" value="317"/>
                    <measurement group_id="B5" value="1277"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>75-84 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="71"/>
                    <measurement group_id="B2" value="76"/>
                    <measurement group_id="B3" value="75"/>
                    <measurement group_id="B4" value="79"/>
                    <measurement group_id="B5" value="301"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>85 and over</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="20"/>
                  </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="331"/>
                    <measurement group_id="B2" value="304"/>
                    <measurement group_id="B3" value="342"/>
                    <measurement group_id="B4" value="318"/>
                    <measurement group_id="B5" value="1295"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="495"/>
                    <measurement group_id="B2" value="518"/>
                    <measurement group_id="B3" value="482"/>
                    <measurement group_id="B4" value="507"/>
                    <measurement group_id="B5" value="2002"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Glycosylated haemoglobin</title>
          <units>percentage of glycosylated haemoglobin</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.67" spread="1.39"/>
                    <measurement group_id="B2" value="8.73" spread="1.51"/>
                    <measurement group_id="B3" value="8.70" spread="1.49"/>
                    <measurement group_id="B4" value="8.70" spread="1.45"/>
                    <measurement group_id="B5" value="8.70" spread="1.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Fasting plasma glucose</title>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="185.4" spread="66.09"/>
                    <measurement group_id="B2" value="182.9" spread="68.04"/>
                    <measurement group_id="B3" value="185.8" spread="68.23"/>
                    <measurement group_id="B4" value="184.6" spread="63.08"/>
                    <measurement group_id="B5" value="184.7" spread="66.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="91.80" spread="20.25"/>
                    <measurement group_id="B2" value="92.86" spread="21.05"/>
                    <measurement group_id="B3" value="91.83" spread="20.35"/>
                    <measurement group_id="B4" value="91.90" spread="20.75"/>
                    <measurement group_id="B5" value="92.09" spread="20.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>LDL-cholesterol</title>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="89.62" spread="39.08"/>
                    <measurement group_id="B2" value="89.72" spread="34.49"/>
                    <measurement group_id="B3" value="89.01" spread="38.35"/>
                    <measurement group_id="B4" value="91.14" spread="37.90"/>
                    <measurement group_id="B5" value="89.87" spread="37.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HDL-cholesterol</title>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45.92" spread="13.00"/>
                    <measurement group_id="B2" value="44.97" spread="12.42"/>
                    <measurement group_id="B3" value="45.82" spread="12.92"/>
                    <measurement group_id="B4" value="44.61" spread="12.26"/>
                    <measurement group_id="B5" value="45.33" spread="12.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Systolic BP</title>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="136.1" spread="17.97"/>
                    <measurement group_id="B2" value="135.8" spread="16.96"/>
                    <measurement group_id="B3" value="135.8" spread="16.16"/>
                    <measurement group_id="B4" value="134.8" spread="17.45"/>
                    <measurement group_id="B5" value="135.6" spread="17.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diastolic BP</title>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="77.10" spread="9.78"/>
                    <measurement group_id="B2" value="76.88" spread="10.21"/>
                    <measurement group_id="B3" value="77.54" spread="9.85"/>
                    <measurement group_id="B4" value="76.66" spread="10.21"/>
                    <measurement group_id="B5" value="77.05" spread="10.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pulse rate</title>
          <units>beats/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="72.69" spread="11.22"/>
                    <measurement group_id="B2" value="71.53" spread="10.86"/>
                    <measurement group_id="B3" value="72.01" spread="10.62"/>
                    <measurement group_id="B4" value="71.95" spread="10.92"/>
                    <measurement group_id="B5" value="72.05" spread="10.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Total cholesterol</title>
          <units>mg/dL</units>
          <param>Geometric Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="165.38" lower_limit="65.25" upper_limit="632.43"/>
                    <measurement group_id="B2" value="164.96" lower_limit="79.54" upper_limit="562.16"/>
                    <measurement group_id="B3" value="164.38" lower_limit="70.27" upper_limit="378.38"/>
                    <measurement group_id="B4" value="165.97" lower_limit="64.86" upper_limit="537.07"/>
                    <measurement group_id="B5" value="165.17" lower_limit="64.86" upper_limit="632.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Triglycerides</title>
          <units>mg/dL</units>
          <param>Geometric Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="163.66" lower_limit="27.59" upper_limit="1913.50"/>
                    <measurement group_id="B2" value="158.93" lower_limit="10.68" upper_limit="3378.44"/>
                    <measurement group_id="B3" value="162.30" lower_limit="30.26" upper_limit="1438.24"/>
                    <measurement group_id="B4" value="163.00" lower_limit="35.60" upper_limit="2435.93"/>
                    <measurement group_id="B5" value="161.96" lower_limit="10.68" upper_limit="3378.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Free fatty acids</title>
          <units>mmol/L</units>
          <param>Geometric Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.83" lower_limit="0.04" upper_limit="3.82"/>
                    <measurement group_id="B2" value="0.80" lower_limit="0.04" upper_limit="4.20"/>
                    <measurement group_id="B3" value="0.83" lower_limit="0.04" upper_limit="3.34"/>
                    <measurement group_id="B4" value="0.81" lower_limit="0.04" upper_limit="4.22"/>
                    <measurement group_id="B5" value="0.82" lower_limit="0.04" upper_limit="4.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Time From Randomisation to First Occurrence of a MACE, Defined as Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke</title>
        <description>Percentage of subjects experiencing a first event of a major adverse cardiovascular event (MACE), defined as cardiovascular (CV) death, non-fatal myocardial infarction (MI), or non-fatal stroke.</description>
        <time_frame>Time from randomisation up to end of follow-up (scheduled at week 109)</time_frame>
        <population>Full analysis set included all the randomised subjects. As specified in the protocol, the two semaglutide dose arms (semaglutide 0.5 mg + semaglutide 1.0 mg) and the two placebo dose arms (placebo 0.5 mg + placebo 1.0 mg) were pooled for the analysis of this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide</title>
            <description>Subjects received once-weekly dose of semaglutide 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects received once-weekly dose of placebo 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Time From Randomisation to First Occurrence of a MACE, Defined as Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke</title>
          <description>Percentage of subjects experiencing a first event of a major adverse cardiovascular event (MACE), defined as cardiovascular (CV) death, non-fatal myocardial infarction (MI), or non-fatal stroke.</description>
          <population>Full analysis set included all the randomised subjects. As specified in the protocol, the two semaglutide dose arms (semaglutide 0.5 mg + semaglutide 1.0 mg) and the two placebo dose arms (placebo 0.5 mg + placebo 1.0 mg) were pooled for the analysis of this endpoint.</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1648"/>
                <count group_id="O2" value="1649"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.6"/>
                    <measurement group_id="O2" value="8.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The primary endpoint was analysed using a stratified Cox proportional hazards model with treatment group (semaglutide, placebo) as fixed factor. Assuming the same population MACE risk for the semaglutide and placebo groups (i.e., the population hazards ratio [HR] equals 1), a total minimum of 122 events were needed in order to have at least 90% power to ascertain that the upper two-sided 95% confidence limit for the HR was less than 1.8.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority of semaglutide versus placebo was considered to be confirmed if the upper limit of the two-sided 95% CI for the HR was below 1.8 or equivalent if the p-value for the one-sided test of: H0: HR ≥ 1.8 against Ha: HR &lt;1.8 was less than 2.5% (or equivalent to 5% for a two-sided test).</non_inferiority_desc>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>The 'p-value' is for the two-sided Wald test of non-inferiority with limit 1.8.</p_value_desc>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.74</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.58</ci_lower_limit>
            <ci_upper_limit>0.95</ci_upper_limit>
            <estimate_desc>Semaglutide/Placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A post hoc analysis of superiority of semaglutide versus placebo was performed based on the pre-specified Cox proportional hazard analysis using the two-sided Wald test of no difference, with treatment (semaglutide, placebo) as fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0167</p_value>
            <p_value_desc>The 'p-value' is for the two-sided Wald test of no difference.</p_value_desc>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.74</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.58</ci_lower_limit>
            <ci_upper_limit>0.95</ci_upper_limit>
            <estimate_desc>Semaglutide/Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time From Randomisation to First Occurrence of an Expanded Composite Cardiovascular Outcome</title>
        <description>Percentage of subjects experiencing first occurrence of an expanded composite CV outcome (defined as either MACE, revascularisation [coronary and peripheral], unstable angina requiring hospitalisation or hospitalisation for heart failure)</description>
        <time_frame>Time from randomisation up to end of follow-up (scheduled at week 109)</time_frame>
        <population>Full analysis set included all the randomised subjects. As specified in the protocol, the two semaglutide dose arms (semaglutide 0.5 mg + semaglutide 1.0 mg) and the two placebo dose arms (placebo 0.5 mg + placebo 1.0 mg) were pooled for the analysis of this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide</title>
            <description>Subjects received once-weekly dose of semaglutide 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects received once-weekly dose of placebo 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Time From Randomisation to First Occurrence of an Expanded Composite Cardiovascular Outcome</title>
          <description>Percentage of subjects experiencing first occurrence of an expanded composite CV outcome (defined as either MACE, revascularisation [coronary and peripheral], unstable angina requiring hospitalisation or hospitalisation for heart failure)</description>
          <population>Full analysis set included all the randomised subjects. As specified in the protocol, the two semaglutide dose arms (semaglutide 0.5 mg + semaglutide 1.0 mg) and the two placebo dose arms (placebo 0.5 mg + placebo 1.0 mg) were pooled for the analysis of this endpoint.</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1648"/>
                <count group_id="O2" value="1649"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.1"/>
                    <measurement group_id="O2" value="16.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Analysis was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0016</p_value>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.74</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.62</ci_lower_limit>
            <ci_upper_limit>0.89</ci_upper_limit>
            <estimate_desc>Semaglutide/Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome</title>
        <description>Percentage of subjects experiencing an event onset for each individual component of the expanded composite cardiovascular outcomes (defined as either MACE, revascularisation [coronary and peripheral], unstable angina requiring hospitalisation or hospitalisation for heart failure).</description>
        <time_frame>Time from randomisation up to end of follow-up (scheduled at week 109)</time_frame>
        <population>Full analysis set included all the randomised subjects. As specified in the protocol, the two semaglutide dose arms (semaglutide 0.5 mg + semaglutide 1.0 mg) and the two placebo dose arms (placebo 0.5 mg + placebo 1.0 mg) were pooled for the analysis of this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide</title>
            <description>Subjects received once-weekly dose of semaglutide 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects received once-weekly dose of placebo 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome</title>
          <description>Percentage of subjects experiencing an event onset for each individual component of the expanded composite cardiovascular outcomes (defined as either MACE, revascularisation [coronary and peripheral], unstable angina requiring hospitalisation or hospitalisation for heart failure).</description>
          <population>Full analysis set included all the randomised subjects. As specified in the protocol, the two semaglutide dose arms (semaglutide 0.5 mg + semaglutide 1.0 mg) and the two placebo dose arms (placebo 0.5 mg + placebo 1.0 mg) were pooled for the analysis of this endpoint.</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1648"/>
                <count group_id="O2" value="1649"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cardiovascular death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6"/>
                    <measurement group_id="O2" value="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-fatal MI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5"/>
                    <measurement group_id="O2" value="3.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-fatal Stroke</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5"/>
                    <measurement group_id="O2" value="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Revascularisation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6"/>
                    <measurement group_id="O2" value="4.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>UAP requiring hospitalisation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1"/>
                    <measurement group_id="O2" value="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hospitalisation for heart failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7"/>
                    <measurement group_id="O2" value="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Analysis for CV death was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.9181</p_value>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.98</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.65</ci_lower_limit>
            <ci_upper_limit>1.48</ci_upper_limit>
            <estimate_desc>Semaglutide/Placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Analysis for non-fatal myocardial infarction was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.1194</p_value>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.74</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.51</ci_lower_limit>
            <ci_upper_limit>1.08</ci_upper_limit>
            <estimate_desc>Semaglutide/Placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Analysis for non-fatal stroke was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0438</p_value>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.61</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.38</ci_lower_limit>
            <ci_upper_limit>0.99</ci_upper_limit>
            <estimate_desc>Semaglutide/Placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Analysis for revascularisation was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0027</p_value>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.65</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.50</ci_lower_limit>
            <ci_upper_limit>0.86</ci_upper_limit>
            <estimate_desc>Semaglutide/Placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Analysis for 'unstable angina requiring hospitalisation' was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.4914</p_value>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.82</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.47</ci_lower_limit>
            <ci_upper_limit>1.44</ci_upper_limit>
            <estimate_desc>Semaglutide/Placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Analysis for hospitalisation for heart failure was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.5735</p_value>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.11</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.77</ci_lower_limit>
            <ci_upper_limit>1.61</ci_upper_limit>
            <estimate_desc>Semaglutide/Placcbo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time From Randomisation to First Occurrence of All-cause Death, Non-fatal MI, or Non-fatal Stroke</title>
        <description>Percentage of subjects experiencing a first occurrence of all-cause death, non-fatal MI, or non-fatal stroke.</description>
        <time_frame>Time from randomisation up to end of follow-up (scheduled at week 109)</time_frame>
        <population>Full analysis set included all the randomised subjects. As specified in the protocol, the two semaglutide dose arms (semaglutide 0.5 mg + semaglutide 1.0 mg) and the two placebo dose arms (placebo 0.5 mg + placebo 1.0 mg) were pooled for the analysis of this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide</title>
            <description>Subjects received once-weekly dose of semaglutide 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects received once-weekly dose of placebo 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Time From Randomisation to First Occurrence of All-cause Death, Non-fatal MI, or Non-fatal Stroke</title>
          <description>Percentage of subjects experiencing a first occurrence of all-cause death, non-fatal MI, or non-fatal stroke.</description>
          <population>Full analysis set included all the randomised subjects. As specified in the protocol, the two semaglutide dose arms (semaglutide 0.5 mg + semaglutide 1.0 mg) and the two placebo dose arms (placebo 0.5 mg + placebo 1.0 mg) were pooled for the analysis of this endpoint.</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1648"/>
                <count group_id="O2" value="1649"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.4"/>
                    <measurement group_id="O2" value="9.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Analysis for all-cause death, non-fatal MI or non-fatal stroke was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0292</p_value>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.77</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.61</ci_lower_limit>
            <ci_upper_limit>0.97</ci_upper_limit>
            <estimate_desc>Semaglutide/Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Glycosylated Haemoglobin (HbA1c)</title>
        <description>Estimated mean change from baseline in glycosylated haemoglobin (HbA1c) to last assessment in the trial during the treatment period.</description>
        <time_frame>Week 0, up to week 104</time_frame>
        <population>Full analysis set included all the randomised subjects</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.5 mg</title>
            <description>Subjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 1.0 mg</title>
            <description>Subjects received once-weekly dose of semaglutide 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo 0.5 mg</title>
            <description>Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Placebo 1.0 mg</title>
            <description>Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Glycosylated Haemoglobin (HbA1c)</title>
          <description>Estimated mean change from baseline in glycosylated haemoglobin (HbA1c) to last assessment in the trial during the treatment period.</description>
          <population>Full analysis set included all the randomised subjects</population>
          <units>percentage of glycosylated haemoglobin</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="826"/>
                <count group_id="O2" value="822"/>
                <count group_id="O3" value="824"/>
                <count group_id="O4" value="825"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.09" spread="0.05"/>
                    <measurement group_id="O2" value="-1.41" spread="0.05"/>
                    <measurement group_id="O3" value="-0.44" spread="0.05"/>
                    <measurement group_id="O4" value="-0.36" spread="0.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Treatment difference</param_type>
            <param_value>-0.66</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.80</ci_lower_limit>
            <ci_upper_limit>-0.52</ci_upper_limit>
            <estimate_desc>Sema 0.5 mg - Placebo 0.5 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Treatment difference</param_type>
            <param_value>-1.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.19</ci_lower_limit>
            <ci_upper_limit>-0.91</ci_upper_limit>
            <estimate_desc>Sema 1.0 mg - Placebo 1.0 mg</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Fasting Plasma Glucose</title>
        <description>Estimated mean change from baseline to last assessment in fasting plasma glucose in the trial during the treatment period.</description>
        <time_frame>Week 0, up to week 104</time_frame>
        <population>Full analysis set included all the randomised subjects.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.5 mg</title>
            <description>Subjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 1.0 mg</title>
            <description>Subjects received once-weekly dose of semaglutide 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo 0.5 mg</title>
            <description>Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Placebo 1.0 mg</title>
            <description>Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Fasting Plasma Glucose</title>
          <description>Estimated mean change from baseline to last assessment in fasting plasma glucose in the trial during the treatment period.</description>
          <population>Full analysis set included all the randomised subjects.</population>
          <units>mmol/L</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="826"/>
                <count group_id="O2" value="822"/>
                <count group_id="O3" value="824"/>
                <count group_id="O4" value="825"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.75" spread="0.12"/>
                    <measurement group_id="O2" value="-2.11" spread="0.12"/>
                    <measurement group_id="O3" value="-1.02" spread="0.12"/>
                    <measurement group_id="O4" value="-0.88" spread="0.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Treatment difference</param_type>
            <param_value>-0.72</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.06</ci_lower_limit>
            <ci_upper_limit>-0.38</ci_upper_limit>
            <estimate_desc>Sema 0.5 mg - Placebo 0.5 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Treatment difference</param_type>
            <param_value>-1.22</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.56</ci_lower_limit>
            <ci_upper_limit>-0.88</ci_upper_limit>
            <estimate_desc>Sema 1.0 mg - Placebo 1.0 mg</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Body Weight</title>
        <description>Estimated mean change from baseline to last assessment in body weight in the trial during the treatment period.</description>
        <time_frame>Week 0, up to week 104</time_frame>
        <population>Full analysis set included all the randomised subjects. As specified in the protocol, the two placebo dose arms (placebo 0.5 mg + placebo 1.0 mg) were pooled for the analysis of this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.5 mg</title>
            <description>Subjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 1.0 mg</title>
            <description>Subjects received once-weekly dose of semaglutide 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Subjects received once-weekly dose of placebo 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Body Weight</title>
          <description>Estimated mean change from baseline to last assessment in body weight in the trial during the treatment period.</description>
          <population>Full analysis set included all the randomised subjects. As specified in the protocol, the two placebo dose arms (placebo 0.5 mg + placebo 1.0 mg) were pooled for the analysis of this endpoint.</population>
          <units>kg</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="826"/>
                <count group_id="O2" value="822"/>
                <count group_id="O3" value="1649"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.57" spread="0.21"/>
                    <measurement group_id="O2" value="-4.88" spread="0.22"/>
                    <measurement group_id="O3" value="-0.62" spread="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Treatment difference</param_type>
            <param_value>-2.95</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.47</ci_lower_limit>
            <ci_upper_limit>-2.44</ci_upper_limit>
            <estimate_desc>Sema 0.5 mg - Placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Treatment difference</param_type>
            <param_value>-4.27</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.78</ci_lower_limit>
            <ci_upper_limit>-3.75</ci_upper_limit>
            <estimate_desc>Semaglutide 1.0 mg - Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Lipid Profile</title>
        <description>Estimated ratio to baseline at week 104 during the treatment period in lipid profile (total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides).</description>
        <time_frame>Week 0, up to week 104</time_frame>
        <population>Full analysis set included all randomised subjects.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.5 mg</title>
            <description>Subjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 1.0 mg</title>
            <description>Subjects received once-weekly dose of semaglutide 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo 0.5 mg</title>
            <description>Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Placebo 1.0 mg</title>
            <description>Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Lipid Profile</title>
          <description>Estimated ratio to baseline at week 104 during the treatment period in lipid profile (total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides).</description>
          <population>Full analysis set included all randomised subjects.</population>
          <units>mg/dL</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="826"/>
                <count group_id="O2" value="822"/>
                <count group_id="O3" value="824"/>
                <count group_id="O4" value="825"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total cholesterol (mg/dL)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.97" spread="0.01"/>
                    <measurement group_id="O2" value="0.97" spread="0.01"/>
                    <measurement group_id="O3" value="1.00" spread="0.01"/>
                    <measurement group_id="O4" value="0.99" spread="0.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HDL-cholesterol (mg/dL)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.99" spread="0.01"/>
                    <measurement group_id="O2" value="1.01" spread="0.01"/>
                    <measurement group_id="O3" value="0.99" spread="0.01"/>
                    <measurement group_id="O4" value="0.97" spread="0.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LDL-cholesterol (mg/dL)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.97" spread="0.01"/>
                    <measurement group_id="O2" value="0.98" spread="0.01"/>
                    <measurement group_id="O3" value="1.01" spread="0.01"/>
                    <measurement group_id="O4" value="0.99" spread="0.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Triglycerides (mg/dL)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.93" spread="0.01"/>
                    <measurement group_id="O2" value="0.92" spread="0.01"/>
                    <measurement group_id="O3" value="0.96" spread="0.01"/>
                    <measurement group_id="O4" value="0.98" spread="0.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis for total cholesterol was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit. The response and its baseline value were log-transformed before analysis.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0149</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Treatment ratio</param_type>
            <param_value>0.97</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.95</ci_lower_limit>
            <ci_upper_limit>1.00</ci_upper_limit>
            <estimate_desc>Semaglutide 0.5 mg/Placebo 0.5 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Analysis for total cholesterol was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit. The response and its baseline value were log-transformed before analysis.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.2580</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Treatment ratio</param_type>
            <param_value>0.99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.97</ci_lower_limit>
            <ci_upper_limit>1.01</ci_upper_limit>
            <estimate_desc>Semaglutide 1.0 mg/Placebo 1.0 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis for HDL-cholesterol was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.8106</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Treatment ratio</param_type>
            <param_value>1.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.99</ci_lower_limit>
            <ci_upper_limit>1.02</ci_upper_limit>
            <estimate_desc>Semaglutide 0.5 mg/Placebo 0.5 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Analysis for HDL-cholesterol was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Treatment ratio</param_type>
            <param_value>1.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.02</ci_lower_limit>
            <ci_upper_limit>1.06</ci_upper_limit>
            <estimate_desc>Semaglutide 1.0 mg/Placebo 1.0 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis for LDL-cholesterol was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0185</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Treatment ratio</param_type>
            <param_value>0.96</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.93</ci_lower_limit>
            <ci_upper_limit>0.99</ci_upper_limit>
            <estimate_desc>Semaglutide 0.5 mg/Placebo 0.5 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Analysis for LDL-cholesterol was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.5996</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Treatment ratio</param_type>
            <param_value>0.99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.96</ci_lower_limit>
            <ci_upper_limit>1.03</ci_upper_limit>
            <estimate_desc>Semaglutide 1.0 mg/Placebo 1.0 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis for triglycerides was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.1833</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Treatment ratio</param_type>
            <param_value>0.97</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.93</ci_lower_limit>
            <ci_upper_limit>1.01</ci_upper_limit>
            <estimate_desc>Semaglutide 0.5 mg/Placebo 0.5 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Analysis for triglycerides was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0009</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Treatment ratio</param_type>
            <param_value>0.93</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.89</ci_lower_limit>
            <ci_upper_limit>0.97</ci_upper_limit>
            <estimate_desc>Semaglutide 1.0 mg/Placebo 1.0 mg</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Urinary Albumin to Creatinine Ratio</title>
        <description>Estimated ratio to baseline in urinary albumin to creatinine ratio at week 104 during the treatment period.</description>
        <time_frame>Week 0, up to week 104</time_frame>
        <population>Full analysis set included all the randomised subjects</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.5 mg</title>
            <description>Subjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 1.0 mg</title>
            <description>Subjects received once-weekly dose of semaglutide 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo 0.5 mg</title>
            <description>Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Placebo 1.0 mg</title>
            <description>Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Urinary Albumin to Creatinine Ratio</title>
          <description>Estimated ratio to baseline in urinary albumin to creatinine ratio at week 104 during the treatment period.</description>
          <population>Full analysis set included all the randomised subjects</population>
          <units>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="826"/>
                <count group_id="O2" value="822"/>
                <count group_id="O3" value="824"/>
                <count group_id="O4" value="825"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.02" spread="0.05"/>
                    <measurement group_id="O2" value="0.91" spread="0.05"/>
                    <measurement group_id="O3" value="1.32" spread="0.07"/>
                    <measurement group_id="O4" value="1.29" spread="0.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis for urinary albumin to creatinine ration was donne using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit. The response and its baseline value were log-transformed before analysis.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0003</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Treatment ratio</param_type>
            <param_value>0.78</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.68</ci_lower_limit>
            <ci_upper_limit>0.89</ci_upper_limit>
            <estimate_desc>Sema 0.5 mg / Placebo 0.5 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Analysis for urinary albumin to creatinine ration was donne using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Treatment ratio</param_type>
            <param_value>0.71</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.62</ci_lower_limit>
            <ci_upper_limit>0.81</ci_upper_limit>
            <estimate_desc>Sema 1.0 mg / Placebo 1.0 mg</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Vital Signs</title>
        <description>Estimated mean change from baseline to last assessment in the trial during the treatment period in vital signs (diastolic blood pressure and systolic blood pressure).</description>
        <time_frame>Week 0, up to week 104</time_frame>
        <population>Full analysis set included all the randomised subjects.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.5 mg</title>
            <description>Subjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 1.0 mg</title>
            <description>Subjects received once-weekly dose of semaglutide 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo 0.5 mg</title>
            <description>Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Placebo 1.0 mg</title>
            <description>Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Vital Signs</title>
          <description>Estimated mean change from baseline to last assessment in the trial during the treatment period in vital signs (diastolic blood pressure and systolic blood pressure).</description>
          <population>Full analysis set included all the randomised subjects.</population>
          <units>mmHg</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="826"/>
                <count group_id="O2" value="822"/>
                <count group_id="O3" value="824"/>
                <count group_id="O4" value="825"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Diastolic blood pressure (mmHg)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.37" spread="0.32"/>
                    <measurement group_id="O2" value="-1.57" spread="0.32"/>
                    <measurement group_id="O3" value="-1.42" spread="0.32"/>
                    <measurement group_id="O4" value="-1.71" spread="0.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Systolic blood pressure (mmHg)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.44" spread="0.54"/>
                    <measurement group_id="O2" value="-5.37" spread="0.54"/>
                    <measurement group_id="O3" value="-2.17" spread="0.54"/>
                    <measurement group_id="O4" value="-2.78" spread="0.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis for diastolic blood pressure was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.9205</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Treatment difference</param_type>
            <param_value>0.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.83</ci_lower_limit>
            <ci_upper_limit>0.92</ci_upper_limit>
            <estimate_desc>Semaglutide 0.5 mg - Placebo 0.5 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Analysis for diastolic blood pressure was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.7477</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Treatment difference</param_type>
            <param_value>0.14</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.74</ci_lower_limit>
            <ci_upper_limit>1.03</ci_upper_limit>
            <estimate_desc>Semaglutide 1.0 mg - Placebo 1.0 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis for systolic blood pressure was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0976</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Treatment difference</param_type>
            <param_value>-1.27</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.77</ci_lower_limit>
            <ci_upper_limit>0.23</ci_upper_limit>
            <estimate_desc>Semaglutide 0.5 mg - Placebo 0.5 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Analysis for systolic blood pressure was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0008</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Treatment difference</param_type>
            <param_value>-2.59</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.09</ci_lower_limit>
            <ci_upper_limit>-1.08</ci_upper_limit>
            <estimate_desc>Semaglutide 1.0 mg - Placebo 1.0 mg</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence During the Trial in Other Treatment Outcomes: Hypoglycaemic Events</title>
        <description>Rates (event rate per 100 exposure years) of severe or blood glucose confirmed symptomatic hypoglycaemia defned as an episode that was severe according to the American diabetic association (ADA) classification or blood glucose (BG) confirmed by a PG value &lt;3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.</description>
        <time_frame>Week 0 - 109</time_frame>
        <population>Full analysis set included all randomised subjects.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.5 mg</title>
            <description>Subjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 1.0 mg</title>
            <description>Subjects received once-weekly dose of semaglutide 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo 0.5 mg</title>
            <description>Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Placebo 1.0 mg</title>
            <description>Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence During the Trial in Other Treatment Outcomes: Hypoglycaemic Events</title>
          <description>Rates (event rate per 100 exposure years) of severe or blood glucose confirmed symptomatic hypoglycaemia defned as an episode that was severe according to the American diabetic association (ADA) classification or blood glucose (BG) confirmed by a PG value &lt;3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.</description>
          <population>Full analysis set included all randomised subjects.</population>
          <units>Event rate per 100 exposure years</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="826"/>
                <count group_id="O2" value="822"/>
                <count group_id="O3" value="824"/>
                <count group_id="O4" value="825"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.5"/>
                    <measurement group_id="O2" value="36.2"/>
                    <measurement group_id="O3" value="35.3"/>
                    <measurement group_id="O4" value="39.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence During the Trial in Other Treatment Outcomes: Adverse Events</title>
        <description>Rates (event rate per 100 years of exposure) of treatment emergent adverse events.</description>
        <time_frame>Weeks 0-109</time_frame>
        <population>Full analysis set included all randomised subjects.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.5 mg</title>
            <description>Subjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 1.0 mg</title>
            <description>Subjects received once-weekly dose of semaglutide 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo 0.5 mg</title>
            <description>Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Placebo 1.0 mg</title>
            <description>Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence During the Trial in Other Treatment Outcomes: Adverse Events</title>
          <description>Rates (event rate per 100 years of exposure) of treatment emergent adverse events.</description>
          <population>Full analysis set included all randomised subjects.</population>
          <units>Event rate per 100 years of exposure</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="826"/>
                <count group_id="O2" value="822"/>
                <count group_id="O3" value="824"/>
                <count group_id="O4" value="825"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="330.5"/>
                    <measurement group_id="O2" value="337.0"/>
                    <measurement group_id="O3" value="317.4"/>
                    <measurement group_id="O4" value="298.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Occurrence During the Trial in Other Treatment Outcomes: Anti-semaglutide Antibodies</title>
        <description>The percentage of subjects that tested positive for anti-semaglutide antibodies at any time point post-baseline during the trial, from week 0 to week 109.</description>
        <time_frame>Weeks 0-109</time_frame>
        <population>Full analysis set included all randomised subjects</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.5 mg</title>
            <description>Subjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 1.0 mg</title>
            <description>Subjects received once-weekly dose of semaglutide 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Occurrence During the Trial in Other Treatment Outcomes: Anti-semaglutide Antibodies</title>
          <description>The percentage of subjects that tested positive for anti-semaglutide antibodies at any time point post-baseline during the trial, from week 0 to week 109.</description>
          <population>Full analysis set included all randomised subjects</population>
          <units>Percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="826"/>
                <count group_id="O2" value="822"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4"/>
                    <measurement group_id="O2" value="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Patient Reported Outcome (PRO)</title>
        <description>Estimated mean change from baseline to last assessment in the trial in patient reported outcomes (PRO). PRO questionnaire (SF-36v2TM) measured the individual overall health related quality of life namely bodily pain, general health, mental component summary, mental health, physical component summary, physical functioning, role-emotional, role-physical, social functioning and vitality. The PRO scores were transformed to a 0-100 scale with higher scores indicating greater health related quality of life.</description>
        <time_frame>Week 0, up to week 104</time_frame>
        <population>Full analysis set included all randomised subjects.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.5 mg</title>
            <description>Subjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 1.0 mg</title>
            <description>Subjects received once-weekly dose of semaglutide 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo 0.5 mg</title>
            <description>Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Placebo 1.0 mg</title>
            <description>Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Patient Reported Outcome (PRO)</title>
          <description>Estimated mean change from baseline to last assessment in the trial in patient reported outcomes (PRO). PRO questionnaire (SF-36v2TM) measured the individual overall health related quality of life namely bodily pain, general health, mental component summary, mental health, physical component summary, physical functioning, role-emotional, role-physical, social functioning and vitality. The PRO scores were transformed to a 0-100 scale with higher scores indicating greater health related quality of life.</description>
          <population>Full analysis set included all randomised subjects.</population>
          <units>Scores 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="826"/>
                <count group_id="O2" value="822"/>
                <count group_id="O3" value="824"/>
                <count group_id="O4" value="825"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Bodily pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.66" spread="0.35"/>
                    <measurement group_id="O2" value="1.82" spread="0.35"/>
                    <measurement group_id="O3" value="0.16" spread="0.35"/>
                    <measurement group_id="O4" value="0.35" spread="0.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>General health</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.66" spread="0.29"/>
                    <measurement group_id="O2" value="2.55" spread="0.29"/>
                    <measurement group_id="O3" value="0.78" spread="0.29"/>
                    <measurement group_id="O4" value="1.13" spread="0.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mental component summary</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="0.35"/>
                    <measurement group_id="O2" value="0.86" spread="0.35"/>
                    <measurement group_id="O3" value="-0.17" spread="0.35"/>
                    <measurement group_id="O4" value="-0.11" spread="0.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mental health</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.48" spread="0.33"/>
                    <measurement group_id="O2" value="1.08" spread="0.33"/>
                    <measurement group_id="O3" value="-0.14" spread="0.33"/>
                    <measurement group_id="O4" value="-0.31" spread="0.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical component summary</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.76" spread="0.28"/>
                    <measurement group_id="O2" value="1.74" spread="0.28"/>
                    <measurement group_id="O3" value="0.07" spread="0.28"/>
                    <measurement group_id="O4" value="0.35" spread="0.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical functioning</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.42" spread="0.32"/>
                    <measurement group_id="O2" value="1.12" spread="0.32"/>
                    <measurement group_id="O3" value="-0.38" spread="0.32"/>
                    <measurement group_id="O4" value="-0.37" spread="0.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role-emotional</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.17" spread="0.42"/>
                    <measurement group_id="O2" value="0.89" spread="0.42"/>
                    <measurement group_id="O3" value="-0.36" spread="0.42"/>
                    <measurement group_id="O4" value="-0.05" spread="0.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role-physical</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.39" spread="0.34"/>
                    <measurement group_id="O2" value="1.18" spread="0.35"/>
                    <measurement group_id="O3" value="-0.33" spread="0.35"/>
                    <measurement group_id="O4" value="0.03" spread="0.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social functioning</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.25" spread="0.35"/>
                    <measurement group_id="O2" value="0.97" spread="0.35"/>
                    <measurement group_id="O3" value="-0.20" spread="0.36"/>
                    <measurement group_id="O4" value="-0.17" spread="0.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vitality</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.29" spread="0.31"/>
                    <measurement group_id="O2" value="1.55" spread="0.31"/>
                    <measurement group_id="O3" value="-0.04" spread="0.31"/>
                    <measurement group_id="O4" value="0.35" spread="0.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis for bodily pain was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.3171</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Treatment difference</param_type>
            <param_value>0.50</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.48</ci_lower_limit>
            <ci_upper_limit>1.47</ci_upper_limit>
            <estimate_desc>Semaglutide 0.5 mg - Placebo 0.5 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Analysis for bodily pain was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0031</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Treatment difference</param_type>
            <param_value>1.47</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.50</ci_lower_limit>
            <ci_upper_limit>2.45</ci_upper_limit>
            <estimate_desc>Semaglutide 1.0 mg - Placebo 1.0 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis for general health was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0350</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Treatment difference</param_type>
            <param_value>0.87</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.06</ci_lower_limit>
            <ci_upper_limit>1.69</ci_upper_limit>
            <estimate_desc>Semaglutide 0.5 mg - Placebo 0.5 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Analysis for general health was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0007</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Treatment difference</param_type>
            <param_value>1.42</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.60</ci_lower_limit>
            <ci_upper_limit>2.24</ci_upper_limit>
            <estimate_desc>Semaglutide 1.0 mg - Placebo 1.0 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis for mental component summary was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.7277</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Treatment difference</param_type>
            <param_value>0.17</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.79</ci_lower_limit>
            <ci_upper_limit>1.13</ci_upper_limit>
            <estimate_desc>Semaglutide 0.5 mg - Placebo 0.5 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Analysis for mental component summary was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0489</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Treatment difference</param_type>
            <param_value>0.97</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.00</ci_lower_limit>
            <ci_upper_limit>1.94</ci_upper_limit>
            <estimate_desc>Semaglutide 1.0 mg - Placebo 1.0 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis for mental health was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.1860</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Treatment Difference</param_type>
            <param_value>0.61</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.30</ci_lower_limit>
            <ci_upper_limit>1.53</ci_upper_limit>
            <estimate_desc>Semaglutide 0.5 mg - Placebo 0.5 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Analysis for mental health was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0029</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Treatment difference</param_type>
            <param_value>1.39</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.48</ci_lower_limit>
            <ci_upper_limit>2.31</ci_upper_limit>
            <estimate_desc>Semaglutide 1.0 mg - Placebo 1.0 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis for physical component summary was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0833</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Treatment difference</param_type>
            <param_value>0.68</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.09</ci_lower_limit>
            <ci_upper_limit>1.45</ci_upper_limit>
            <estimate_desc>Semaglutide 0.5 mg - Placebo 0.5 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Analysis for physical component summary was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0004</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Treatment difference</param_type>
            <param_value>1.40</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.62</ci_lower_limit>
            <ci_upper_limit>2.17</ci_upper_limit>
            <estimate_desc>Semaglutide 1.0 mg - Placebo 1.0 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis for physical functioning was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0799</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Treatment difference</param_type>
            <param_value>0.80</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.10</ci_lower_limit>
            <ci_upper_limit>1.69</ci_upper_limit>
            <estimate_desc>Semaglutide 0.5 mg - Placebo 0.5 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Analysis for physical functioning was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0011</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Treatment difference</param_type>
            <param_value>1.50</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.60</ci_lower_limit>
            <ci_upper_limit>2.40</ci_upper_limit>
            <estimate_desc>Semaglutide 1.0 mg - Placebo 1.0 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis for role emotional was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.3717</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Treatment difference</param_type>
            <param_value>0.53</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.63</ci_lower_limit>
            <ci_upper_limit>1.68</ci_upper_limit>
            <estimate_desc>Semaglutide 0.5 mg - Placebo 0.5 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Analysis for role emotional was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.1136</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Treatment difference</param_type>
            <param_value>0.94</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.22</ci_lower_limit>
            <ci_upper_limit>2.10</ci_upper_limit>
            <estimate_desc>Semaglutide 1.0 mg - Placebo 1.0 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis for role physical was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.1431</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Treatment difference</param_type>
            <param_value>0.72</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.24</ci_lower_limit>
            <ci_upper_limit>1.67</ci_upper_limit>
            <estimate_desc>Semaglutide 0.5 mg - Placebo 0.5 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Analysis for role physical was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0197</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Treatment difference</param_type>
            <param_value>1.14</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.18</ci_lower_limit>
            <ci_upper_limit>2.11</ci_upper_limit>
            <estimate_desc>Semaglutide 1.0 mg - Placebo 1.0 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis for social functioning was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.9223</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Treatment difference</param_type>
            <param_value>-0.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.03</ci_lower_limit>
            <ci_upper_limit>0.93</ci_upper_limit>
            <estimate_desc>Semaglutide 0.5 mg - Placebo 0.5 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Analysis for social functioning was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0237</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Treatment difference</param_type>
            <param_value>1.14</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.15</ci_lower_limit>
            <ci_upper_limit>2.13</ci_upper_limit>
            <estimate_desc>Semaglutide 1.0 mg - Placebo 1.0 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis for vitality was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.4523</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Treatment difference</param_type>
            <param_value>0.33</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.53</ci_lower_limit>
            <ci_upper_limit>1.19</ci_upper_limit>
            <estimate_desc>Semaglutide 0.5 mg - Placebo 0.5 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Analysis for vitality was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0064</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Treatment difference</param_type>
            <param_value>1.20</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.34</ci_lower_limit>
            <ci_upper_limit>2.07</ci_upper_limit>
            <estimate_desc>Semaglutide 1.0 mg - Placebo 1.0 mg</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Lipid Profile (Free Fatty Acids)</title>
        <description>Estimated ratio to baseline at week 104 during the treatment period in lipid profile (free fatty acids).</description>
        <time_frame>Week 0, up to week 104</time_frame>
        <population>Full analysis set included all randomised subjects.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.5 mg</title>
            <description>Subjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 1.0 mg</title>
            <description>Subjects received once-weekly dose of semaglutide 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo 0.5 mg</title>
            <description>Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Placebo 1.0 mg</title>
            <description>Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Lipid Profile (Free Fatty Acids)</title>
          <description>Estimated ratio to baseline at week 104 during the treatment period in lipid profile (free fatty acids).</description>
          <population>Full analysis set included all randomised subjects.</population>
          <units>mmol/L</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="826"/>
                <count group_id="O2" value="822"/>
                <count group_id="O3" value="824"/>
                <count group_id="O4" value="825"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.95" spread="0.02"/>
                    <measurement group_id="O2" value="0.91" spread="0.01"/>
                    <measurement group_id="O3" value="0.96" spread="0.02"/>
                    <measurement group_id="O4" value="0.99" spread="0.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis for free fatty acids was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.7796</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Treatment ratio</param_type>
            <param_value>0.99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.95</ci_lower_limit>
            <ci_upper_limit>1.04</ci_upper_limit>
            <estimate_desc>Semaglutide 0.5 mg/Placebo 0.5 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Analysis for free fatty acids was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0003</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Treatment ratio</param_type>
            <param_value>0.92</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.88</ci_lower_limit>
            <ci_upper_limit>0.96</ci_upper_limit>
            <estimate_desc>Semaglutide 1.0 mg/Placebo 1.0 mg</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Vital Signs (Pulse Rate)</title>
        <description>Estimated mean change from baseline to last assessment in the trial during the treatment period in vital signs (pulse rate).</description>
        <time_frame>Week 0, up to week 104</time_frame>
        <population>Full analysis set included all the randomised subjects.</population>
        <group_list>
          <group group_id="O1">
            <title>Semaglutide 0.5 mg</title>
            <description>Subjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Semaglutide 1.0 mg</title>
            <description>Subjects received once-weekly dose of semaglutide 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo 0.5 mg</title>
            <description>Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Placebo 1.0 mg</title>
            <description>Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Vital Signs (Pulse Rate)</title>
          <description>Estimated mean change from baseline to last assessment in the trial during the treatment period in vital signs (pulse rate).</description>
          <population>Full analysis set included all the randomised subjects.</population>
          <units>beats/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="826"/>
                <count group_id="O2" value="822"/>
                <count group_id="O3" value="824"/>
                <count group_id="O4" value="825"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.12" spread="0.34"/>
                    <measurement group_id="O2" value="2.41" spread="0.34"/>
                    <measurement group_id="O3" value="0.09" spread="0.34"/>
                    <measurement group_id="O4" value="-0.07" spread="0.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis for pulse rate was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Treatment difference</param_type>
            <param_value>2.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.07</ci_lower_limit>
            <ci_upper_limit>2.98</ci_upper_limit>
            <estimate_desc>Semaglutide 0.5 mg - Placebo 0.5 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Analysis for pulse rate was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Treatment difference</param_type>
            <param_value>2.47</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.52</ci_lower_limit>
            <ci_upper_limit>3.43</ci_upper_limit>
            <estimate_desc>Semaglutide 1.0 mg - Placebo 1.0 mg</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).</time_frame>
      <desc>Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.</desc>
      <group_list>
        <group group_id="E1">
          <title>Semaglutide 0.5 mg</title>
          <description>Subjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.</description>
        </group>
        <group group_id="E2">
          <title>Semaglutide 1.0 mg</title>
          <description>Subjects received once-weekly dose of semaglutide 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.</description>
        </group>
        <group group_id="E3">
          <title>Placebo 0.5 mg</title>
          <description>Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.</description>
        </group>
        <group group_id="E4">
          <title>Placebo 1.0 mg</title>
          <description>Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 18</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="289" subjects_at_risk="826"/>
                <counts group_id="E2" subjects_affected="276" subjects_at_risk="822"/>
                <counts group_id="E3" subjects_affected="329" subjects_at_risk="824"/>
                <counts group_id="E4" subjects_affected="298" subjects_at_risk="825"/>
              </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="5" subjects_affected="5" subjects_at_risk="826"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="822"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="824"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Haemorrhagic anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Iron deficiency anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Lymphadenopathy mediastinal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Microcytic anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Splenic vein thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Splenomegaly</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="826"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Acute left ventricular failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="21" subjects_affected="16" subjects_at_risk="826"/>
                <counts group_id="E2" events="14" subjects_affected="13" subjects_at_risk="822"/>
                <counts group_id="E3" events="15" subjects_affected="15" subjects_at_risk="824"/>
                <counts group_id="E4" events="28" subjects_affected="27" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="826"/>
                <counts group_id="E2" events="10" subjects_affected="9" subjects_at_risk="822"/>
                <counts group_id="E3" events="17" subjects_affected="16" subjects_at_risk="824"/>
                <counts group_id="E4" events="12" subjects_affected="12" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" events="16" subjects_affected="13" subjects_at_risk="826"/>
                <counts group_id="E2" events="18" subjects_affected="15" subjects_at_risk="822"/>
                <counts group_id="E3" events="21" subjects_affected="19" subjects_at_risk="824"/>
                <counts group_id="E4" events="23" subjects_affected="22" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Aortic valve disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Aortic valve stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Arteriosclerosis coronary artery</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="16" subjects_affected="14" subjects_at_risk="826"/>
                <counts group_id="E2" events="15" subjects_affected="12" subjects_at_risk="822"/>
                <counts group_id="E3" events="22" subjects_affected="20" subjects_at_risk="824"/>
                <counts group_id="E4" events="19" subjects_affected="18" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Atrioventricular block</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Atrioventricular block complete</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="824"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Atrioventricular block first degree</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Atrioventricular block second degree</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="824"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Bundle branch block left</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Bundle branch block right</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="826"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="822"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="824"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Cardiac asthma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="11" subjects_affected="10" subjects_at_risk="826"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="822"/>
                <counts group_id="E3" events="9" subjects_affected="7" subjects_at_risk="824"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Cardiac failure acute</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="824"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Cardiac failure chronic</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="826"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="822"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="824"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" events="31" subjects_affected="21" subjects_at_risk="826"/>
                <counts group_id="E2" events="17" subjects_affected="14" subjects_at_risk="822"/>
                <counts group_id="E3" events="19" subjects_affected="15" subjects_at_risk="824"/>
                <counts group_id="E4" events="21" subjects_affected="18" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Cardiac tamponade</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Cardiac ventricular thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Cardio-respiratory arrest</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Cardiogenic shock</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Cardiomyopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Cardiopulmonary failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Cardiovascular insufficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Congestive cardiomyopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="826"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="822"/>
                <counts group_id="E3" events="6" subjects_affected="5" subjects_at_risk="824"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Coronary artery insufficiency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Coronary artery occlusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Coronary artery stenosis</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="826"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="822"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Diabetic cardiomyopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Hypertensive cardiomyopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Ischaemic cardiomyopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Left ventricular failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Mitral valve incompetence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="826"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="822"/>
                <counts group_id="E3" events="10" subjects_affected="9" subjects_at_risk="824"/>
                <counts group_id="E4" events="14" subjects_affected="12" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Myocardial ischaemia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="826"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="822"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="824"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Myocarditis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Nodal arrhythmia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Pericardial effusion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Right ventricular failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Silent myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Sinus bradycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Sinus node dysfunction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="822"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Supraventricular extrasystoles</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="826"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="822"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Tricuspid valve incompetence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Ventricular arrhythmia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Ventricular asystole</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Ventricular extrasystoles</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Ventricular fibrillation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Ventricular hypokinesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Ventricular tachyarrhythmia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Ventricular tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="822"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Atrial thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Bradyarrhythmia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Cor pulmonale acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Pulmonary valve stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Stress cardiomyopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Phimosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Deafness neurosensory</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Otosclerosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Tympanic membrane perforation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Goitre</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Hyperthyroidism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Inappropriate antidiuretic hormone secretion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Thyroid mass</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Blindness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="6" subjects_affected="5" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Cataract cortical</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Cataract nuclear</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Cystoid macular oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Diabetic retinopathy</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="826"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="822"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="824"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Diplopia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Eyelid dermatochalasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Eyelid ptosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Glaucoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Iridocyclitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Macular fibrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Macular oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Open angle glaucoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Optic ischaemic neuropathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Retinal artery occlusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Retinal degeneration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Retinal detachment</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Retinopathy haemorrhagic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Vitreous haemorrhage</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="826"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Amaurosis fugax</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal mass</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="826"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="822"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="824"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Change of bowel habit</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Chronic gastritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Colitis ischaemic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Colitis ulcerative</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="826"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="822"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Diverticulum</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Diverticulum intestinal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Duodenal ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Duodenal ulcer haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Duodenitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Enterocolitis haemorrhagic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Epigastric discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Faeces discoloured</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Gastric disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Gastric ileus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Gastric polyps</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Gastric ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Gastric ulcer haemorrhage</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Gastritis haemorrhagic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Gastroduodenitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Gastrointestinal ischaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="826"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Hiatus hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Impaired gastric emptying</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Intestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Intestinal ischaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Large intestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Large intestine polyp</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Lower gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Melaena</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Mouth ulceration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Pancreatic cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Peptic ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Peritoneal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Proctitis haemorrhagic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Rectal prolapse</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Umbilical hernia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Volvulus of small bowel</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="822"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="824"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Diaphragmatic hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Haematemesis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Intestinal perforation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Oesophageal spasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Pneumoperitoneum</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="822"/>
                <counts group_id="E3" events="6" subjects_affected="5" subjects_at_risk="824"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="826"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="822"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="824"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Device malfunction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Gait disturbance</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Generalised oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Hyperthermia malignant</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Impaired healing</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Metaplasia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Microlithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Multi-organ failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Necrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="826"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="822"/>
                <counts group_id="E3" events="8" subjects_affected="8" subjects_at_risk="824"/>
                <counts group_id="E4" events="5" subjects_affected="4" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Sudden cardiac death</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Sudden death</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Drug intolerance</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Bile duct stone</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="822"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Biliary colic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Cholangitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="824"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="824"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Cholecystitis chronic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="826"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="822"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Cholelithiasis obstructive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Cholestasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Gallbladder necrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Gallbladder polyp</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Hepatic cirrhosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Hepatic congestion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Hydrocholecystis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Ischaemic hepatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Jaundice</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Hepatic failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Pneumobilia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaphylactic shock</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Drug hypersensitivity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Sarcoidosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Abscess limb</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Acute hepatitis B</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Boutonneuse fever</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="826"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="822"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="824"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Bronchopneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Campylobacter gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Campylobacter infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="826"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="822"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="824"/>
                <counts group_id="E4" events="10" subjects_affected="9" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Dengue fever</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Device related sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Diabetic foot infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="822"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Endocarditis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Enteritis infectious</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Enterococcal infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Epididymitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Escherichia infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Escherichia sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Gangrene</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="824"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="822"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="824"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Gastroenteritis rotavirus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Gastroenteritis salmonella</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Implant site infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Incision site infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Infected skin ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Infectious colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Infective exacerbation of chronic obstructive airways disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="824"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Labyrinthitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Liver abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Lobar pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Localised infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="822"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="824"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Meningitis bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Necrotising fasciitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Oesophageal candidiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="824"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Otitis externa</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Paronychia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Perirectal abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Peritonsillar abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Periumbilical abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="19" subjects_affected="18" subjects_at_risk="826"/>
                <counts group_id="E2" events="16" subjects_affected="15" subjects_at_risk="822"/>
                <counts group_id="E3" events="26" subjects_affected="22" subjects_at_risk="824"/>
                <counts group_id="E4" events="14" subjects_affected="14" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Pneumonia pneumococcal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Post procedural infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Post procedural pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Postoperative wound infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Pseudomembranous colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Pulmonary sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Pyelonephritis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Pyelonephritis chronic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection viral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="826"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="822"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="824"/>
                <counts group_id="E4" events="7" subjects_affected="7" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="824"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="824"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Soft tissue infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Splenic abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Staphylococcal infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Staphylococcal osteomyelitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Staphylococcal sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Subcutaneous abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Tooth abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Tuberculosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="826"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="822"/>
                <counts group_id="E3" events="10" subjects_affected="10" subjects_at_risk="824"/>
                <counts group_id="E4" events="6" subjects_affected="6" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Urinary tract infection pseudomonal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Urinary tract infection staphylococcal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Vestibular neuronitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Abdominal sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Aspergilloma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Bronchitis bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Gastritis viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Groin abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Laryngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Pneumonia respiratory syncytial viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Septic encephalopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Staphylococcal bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Wound infection bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Accident at work</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Anaemia postoperative</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Animal bite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Ankle fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Dural tear</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Failure to anastomose</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="826"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="822"/>
                <counts group_id="E3" events="11" subjects_affected="11" subjects_at_risk="824"/>
                <counts group_id="E4" events="8" subjects_affected="8" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Foot fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Hand fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Head injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Incorrect dose administered</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Intentional overdose</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Meniscus injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Muscle strain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Overdose</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Post procedural haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Postoperative ileus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Postoperative respiratory failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Radius fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="826"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="822"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="824"/>
                <counts group_id="E4" events="5" subjects_affected="4" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Scapula fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Seroma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Skin abrasion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Skull fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Spinal compression fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Tendon rupture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Thermal burn</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Toxicity to various agents</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Traumatic fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Traumatic haemothorax</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Traumatic ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Vascular graft complication</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Vascular graft occlusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Vascular pseudoaneurysm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Wound</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Wound necrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Wrong drug administered</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Alcohol poisoning</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Burns third degree</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Cervical vertebral fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Incisional hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Lumbar vertebral fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Near drowning</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Amylase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Arteriogram coronary</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Bacterial test positive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Blood glucose fluctuation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Blood glucose increased</sub_title>
                <counts group_id="E1" events="6" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Blood urea increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Catheterisation cardiac</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Ejection fraction decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Electrocardiogram QT prolonged</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Electrocardiogram ST segment abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Electrocardiogram T wave inversion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Electrocardiogram change</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Liver function test abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Pancreatic enzymes increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Troponin increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Coagulation time prolonged</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Acidosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="826"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="822"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus inadequate control</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="7" subjects_affected="5" subjects_at_risk="824"/>
                <counts group_id="E4" events="5" subjects_affected="4" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Diabetic ketoacidosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Electrolyte imbalance</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Failure to thrive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Fluid overload</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="826"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="822"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="824"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="826"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="822"/>
                <counts group_id="E3" events="7" subjects_affected="5" subjects_at_risk="824"/>
                <counts group_id="E4" events="6" subjects_affected="6" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Hypovolaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Lactic acidosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Obesity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Metabolic acidosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Metabolic disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="6" subjects_affected="6" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Chondrolysis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Costochondritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Diabetic arthropathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Fibromyalgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Foot deformity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Intervertebral disc disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Lumbar spinal stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="822"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="824"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="826"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="822"/>
                <counts group_id="E3" events="9" subjects_affected="9" subjects_at_risk="824"/>
                <counts group_id="E4" events="10" subjects_affected="10" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Osteonecrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Rheumatoid arthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Spinal column stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="4" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Spinal osteoarthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Synovial cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Mobility decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Soft tissue disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Acute lymphocytic leukaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Acute myeloid leukaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Adenocarcinoma gastric</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Adenocarcinoma of colon</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Adenocarcinoma pancreas</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Anaplastic astrocytoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>B-cell lymphoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>B-cell small lymphocytic lymphoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Benign lymph node neoplasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Benign neoplasm of thyroid gland</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Bladder neoplasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Bladder papilloma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Bladder transitional cell carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Bladder transitional cell carcinoma recurrent</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Bladder transitional cell carcinoma stage II</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Bone cancer metastatic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Breast cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Breast cancer in situ</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Breast cancer stage III</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Bronchial carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Cholangiocarcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Cholesteatoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Choroid melanoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Chronic lymphocytic leukaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Clear cell renal cell carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Colon adenoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Colon cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Colon cancer metastatic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Colon neoplasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Colorectal cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Endometrial adenocarcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Endometrial sarcoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Extranodal marginal zone B-cell lymphoma (MALT type)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Gallbladder adenocarcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Gastric cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Glomus tumour</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Growth hormone-producing pituitary tumour</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Hepatic adenoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Hepatic cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Invasive ductal breast carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Laryngeal squamous cell carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Lip neoplasm malignant stage unspecified</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Lung adenocarcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Lung adenocarcinoma stage IV</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Lung carcinoma cell type unspecified stage IV</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Lung neoplasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Lung neoplasm malignant</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Malignant melanoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Metastases to central nervous system</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Metastases to liver</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Metastases to lung</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Metastases to lymph nodes</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Metastatic gastric cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Neoplasm of appendix</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Non-small cell lung cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Ovarian epithelial cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Ovarian germ cell teratoma benign</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Pancreatic carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Pancreatic carcinoma metastatic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Papillary thyroid cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Paraganglion neoplasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Parathyroid tumour benign</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="824"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Phaeochromocytoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Plasma cell myeloma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="826"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="822"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Prostate cancer metastatic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Prostate cancer recurrent</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Prostate cancer stage I</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Prostate cancer stage III</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Rectal cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Renal cancer metastatic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Renal cancer stage I</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Renal cell carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Small cell lung cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="822"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of lung</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of skin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Thyroid neoplasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Transitional cell carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Ureteric cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Uterine leiomyoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Brain neoplasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Chondroma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Invasive breast carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Lung adenocarcinoma stage 0</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Metastases to bone</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Pancreatic carcinoma stage IV</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Thyroid cancer metastatic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Brain oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Brain stem infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Carotid artery stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="824"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Cerebellar haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Cerebellar syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Cerebral haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="826"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="822"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Cerebral ischaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Cerebrospinal fluid leakage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="826"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="822"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="824"/>
                <counts group_id="E4" events="8" subjects_affected="6" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Cerebrovascular disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Cervical myelopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Cervical radiculopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Chronic inflammatory demyelinating polyradiculoneuropathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Coma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Coordination abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Diabetic mononeuropathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Embolic stroke</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Epilepsy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Haemorrhage intracranial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Haemorrhagic stroke</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Hepatic encephalopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Hydrocephalus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Hypertensive encephalopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Hypoglycaemic unconsciousness</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="826"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="6" subjects_affected="3" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Hypoxic-ischaemic encephalopathy</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Intracranial aneurysm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Intracranial hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Intraventricular haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Ischaemic cerebral infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="826"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="822"/>
                <counts group_id="E3" events="16" subjects_affected="16" subjects_at_risk="824"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Lacunar infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Loss of consciousness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Metabolic encephalopathy</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Movement disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Multiple sclerosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Neuralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Parkinsonism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="822"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Radiculitis lumbosacral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Radiculopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="826"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="822"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="824"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Thalamic infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="826"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="822"/>
                <counts group_id="E3" events="10" subjects_affected="10" subjects_at_risk="824"/>
                <counts group_id="E4" events="7" subjects_affected="7" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>VIIth nerve paralysis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>VIth nerve disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Vascular parkinsonism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Visual field defect</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Carotid artery occlusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Cranial nerve disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Hypoglycaemic coma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Myelitis transverse</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Speech disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </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="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="822"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Mental status changes</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="824"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Post-traumatic stress disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Schizoaffective disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Sleep terror</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Homicidal ideation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="22" subjects_affected="18" subjects_at_risk="826"/>
                <counts group_id="E2" events="8" subjects_affected="6" subjects_at_risk="822"/>
                <counts group_id="E3" events="14" subjects_affected="14" subjects_at_risk="824"/>
                <counts group_id="E4" events="24" subjects_affected="22" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Acute prerenal failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Azotaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Bladder trabeculation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Calculus ureteric</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="826"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="822"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Calculus urinary</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Chronic kidney disease</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="826"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="822"/>
                <counts group_id="E3" events="17" subjects_affected="14" subjects_at_risk="824"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Glomerulonephritis chronic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Hydronephrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="826"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Nephropathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Nephrotic syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Renal artery arteriosclerosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Renal colic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Renal cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="826"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Stag horn calculus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Urethral stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Urinary bladder polyp</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Urinary incontinence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Anuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Diabetic end stage renal disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Renal artery stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Benign prostatic hyperplasia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="826"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Cystocele</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Endometrial hyperplasia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Epididymal tenderness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Erectile dysfunction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Menorrhagia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Ovarian cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Prostatic obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Prostatomegaly</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Testicular cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Uterine polyp</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Vaginal prolapse</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Breast cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Genital haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acquired diaphragmatic eventration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Acute pulmonary oedema</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="826"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Atelectasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="6" subjects_affected="3" subjects_at_risk="826"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="822"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="824"/>
                <counts group_id="E4" events="9" subjects_affected="7" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="826"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="822"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="824"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Dyspnoea at rest</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Hydrothorax</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Laryngeal stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Pleurisy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Pulmonary congestion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="826"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="822"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="824"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Pulmonary hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Pulmonary mass</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Pulmonary oedema</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="824"/>
                <counts group_id="E4" events="6" subjects_affected="5" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Respiratory arrest</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Respiratory distress</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="826"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="822"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="824"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Bronchitis chronic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Bronchospasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Hyperventilation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Idiopathic pulmonary fibrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Lung cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Actinic keratosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Angioedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Decubitus ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Diabetic foot</sub_title>
                <counts group_id="E1" events="8" subjects_affected="6" subjects_at_risk="826"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="822"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="824"/>
                <counts group_id="E4" events="8" subjects_affected="5" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Hyperkeratosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Psoriasis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Rash papular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Skin necrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Skin ulcer</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Stevens-Johnson syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Abdominal hernia repair</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Angioplasty</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Brachytherapy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Carotid angioplasty</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Carotid artery stent insertion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Carotid endarterectomy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="824"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Carotid revascularisation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Cataract operation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Coronary angioplasty</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="824"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Coronary arterial stent insertion</sub_title>
                <counts group_id="E1" events="19" subjects_affected="15" subjects_at_risk="826"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="822"/>
                <counts group_id="E3" events="18" subjects_affected="17" subjects_at_risk="824"/>
                <counts group_id="E4" events="19" subjects_affected="17" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Coronary artery bypass</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="826"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="822"/>
                <counts group_id="E3" events="14" subjects_affected="14" subjects_at_risk="824"/>
                <counts group_id="E4" events="10" subjects_affected="10" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Coronary revascularisation</sub_title>
                <counts group_id="E1" events="12" subjects_affected="11" subjects_at_risk="826"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="822"/>
                <counts group_id="E3" events="17" subjects_affected="15" subjects_at_risk="824"/>
                <counts group_id="E4" events="10" subjects_affected="9" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Hospitalisation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Laparotomy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Mechanical ventilation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Nasal polypectomy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Percutaneous coronary intervention</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="824"/>
                <counts group_id="E4" events="7" subjects_affected="6" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Peripheral artery angioplasty</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Peripheral artery bypass</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Peripheral artery stent insertion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Peripheral endarterectomy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Peripheral revascularisation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="826"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="822"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="824"/>
                <counts group_id="E4" events="9" subjects_affected="9" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Pterygium operation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Removal of internal fixation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Stent placement</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="826"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Umbilical hernia repair</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Renal artery stent placement</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Tendon sheath incision</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic aneurysm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Aortic dissection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Aortic stenosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Arterial insufficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Circulatory collapse</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Extremity necrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Femoral artery occlusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="824"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Hypertensive crisis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Hypertensive emergency</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="824"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Intra-abdominal haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Peripheral arterial occlusive disease</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="826"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Peripheral artery aneurysm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Peripheral artery stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Peripheral artery thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Peripheral ischaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Peripheral vascular disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="824"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Shock haemorrhagic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Temporal arteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Varicose vein</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Vasculitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="822"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Femoral artery aneurysm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Leriche syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="826"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="822"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="824"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="825"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 18</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="573" subjects_at_risk="826"/>
                <counts group_id="E2" subjects_affected="587" subjects_at_risk="822"/>
                <counts group_id="E3" subjects_affected="547" subjects_at_risk="824"/>
                <counts group_id="E4" subjects_affected="524" subjects_at_risk="825"/>
              </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="46" subjects_affected="41" subjects_at_risk="826"/>
                <counts group_id="E2" events="34" subjects_affected="33" subjects_at_risk="822"/>
                <counts group_id="E3" events="46" subjects_affected="44" subjects_at_risk="824"/>
                <counts group_id="E4" events="55" subjects_affected="48" subjects_at_risk="825"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" events="59" subjects_affected="55" subjects_at_risk="826"/>
                <counts group_id="E2" events="48" subjects_affected="43" subjects_at_risk="822"/>
                <counts group_id="E3" events="38" subjects_affected="37" subjects_at_risk="824"/>
                <counts group_id="E4" events="46" subjects_affected="45" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Diabetic retinopathy</sub_title>
                <counts group_id="E1" events="50" subjects_affected="46" subjects_at_risk="826"/>
                <counts group_id="E2" events="63" subjects_affected="56" subjects_at_risk="822"/>
                <counts group_id="E3" events="39" subjects_affected="39" subjects_at_risk="824"/>
                <counts group_id="E4" events="43" subjects_affected="38" subjects_at_risk="825"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="54" subjects_affected="45" subjects_at_risk="826"/>
                <counts group_id="E2" events="40" subjects_affected="35" subjects_at_risk="822"/>
                <counts group_id="E3" events="37" subjects_affected="33" subjects_at_risk="824"/>
                <counts group_id="E4" events="36" subjects_affected="31" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="37" subjects_affected="35" subjects_at_risk="826"/>
                <counts group_id="E2" events="53" subjects_affected="42" subjects_at_risk="822"/>
                <counts group_id="E3" events="22" subjects_affected="19" subjects_at_risk="824"/>
                <counts group_id="E4" events="33" subjects_affected="19" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="52" subjects_affected="46" subjects_at_risk="826"/>
                <counts group_id="E2" events="97" subjects_affected="79" subjects_at_risk="822"/>
                <counts group_id="E3" events="42" subjects_affected="37" subjects_at_risk="824"/>
                <counts group_id="E4" events="38" subjects_affected="36" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="277" subjects_affected="148" subjects_at_risk="826"/>
                <counts group_id="E2" events="245" subjects_affected="148" subjects_at_risk="822"/>
                <counts group_id="E3" events="159" subjects_affected="97" subjects_at_risk="824"/>
                <counts group_id="E4" events="112" subjects_affected="87" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="68" subjects_affected="51" subjects_at_risk="826"/>
                <counts group_id="E2" events="88" subjects_affected="63" subjects_at_risk="822"/>
                <counts group_id="E3" events="25" subjects_affected="23" subjects_at_risk="824"/>
                <counts group_id="E4" events="19" subjects_affected="18" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="233" subjects_affected="143" subjects_at_risk="826"/>
                <counts group_id="E2" events="282" subjects_affected="179" subjects_at_risk="822"/>
                <counts group_id="E3" events="78" subjects_affected="62" subjects_at_risk="824"/>
                <counts group_id="E4" events="94" subjects_affected="66" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="128" subjects_affected="87" subjects_at_risk="826"/>
                <counts group_id="E2" events="170" subjects_affected="122" subjects_at_risk="822"/>
                <counts group_id="E3" events="51" subjects_affected="42" subjects_at_risk="824"/>
                <counts group_id="E4" events="41" subjects_affected="33" subjects_at_risk="825"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="27" subjects_affected="24" subjects_at_risk="826"/>
                <counts group_id="E2" events="48" subjects_affected="42" subjects_at_risk="822"/>
                <counts group_id="E3" events="16" subjects_affected="15" subjects_at_risk="824"/>
                <counts group_id="E4" events="28" subjects_affected="26" subjects_at_risk="825"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="52" subjects_affected="46" subjects_at_risk="826"/>
                <counts group_id="E2" events="43" subjects_affected="38" subjects_at_risk="822"/>
                <counts group_id="E3" events="52" subjects_affected="49" subjects_at_risk="824"/>
                <counts group_id="E4" events="64" subjects_affected="51" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="60" subjects_affected="51" subjects_at_risk="826"/>
                <counts group_id="E2" events="56" subjects_affected="48" subjects_at_risk="822"/>
                <counts group_id="E3" events="57" subjects_affected="48" subjects_at_risk="824"/>
                <counts group_id="E4" events="63" subjects_affected="46" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="91" subjects_affected="66" subjects_at_risk="826"/>
                <counts group_id="E2" events="77" subjects_affected="60" subjects_at_risk="822"/>
                <counts group_id="E3" events="99" subjects_affected="78" subjects_at_risk="824"/>
                <counts group_id="E4" events="84" subjects_affected="66" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="59" subjects_affected="53" subjects_at_risk="826"/>
                <counts group_id="E2" events="64" subjects_affected="51" subjects_at_risk="822"/>
                <counts group_id="E3" events="75" subjects_affected="63" subjects_at_risk="824"/>
                <counts group_id="E4" events="88" subjects_affected="65" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="108" subjects_affected="78" subjects_at_risk="826"/>
                <counts group_id="E2" events="93" subjects_affected="71" subjects_at_risk="822"/>
                <counts group_id="E3" events="97" subjects_affected="64" subjects_at_risk="824"/>
                <counts group_id="E4" events="87" subjects_affected="68" subjects_at_risk="825"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Amylase increased</sub_title>
                <counts group_id="E1" events="39" subjects_affected="31" subjects_at_risk="826"/>
                <counts group_id="E2" events="57" subjects_affected="48" subjects_at_risk="822"/>
                <counts group_id="E3" events="33" subjects_affected="28" subjects_at_risk="824"/>
                <counts group_id="E4" events="33" subjects_affected="28" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" events="121" subjects_affected="94" subjects_at_risk="826"/>
                <counts group_id="E2" events="123" subjects_affected="90" subjects_at_risk="822"/>
                <counts group_id="E3" events="76" subjects_affected="66" subjects_at_risk="824"/>
                <counts group_id="E4" events="83" subjects_affected="69" subjects_at_risk="825"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="97" subjects_affected="86" subjects_at_risk="826"/>
                <counts group_id="E2" events="88" subjects_affected="75" subjects_at_risk="822"/>
                <counts group_id="E3" events="21" subjects_affected="19" subjects_at_risk="824"/>
                <counts group_id="E4" events="10" subjects_affected="9" subjects_at_risk="825"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="45" subjects_affected="41" subjects_at_risk="826"/>
                <counts group_id="E2" events="40" subjects_affected="35" subjects_at_risk="822"/>
                <counts group_id="E3" events="69" subjects_affected="57" subjects_at_risk="824"/>
                <counts group_id="E4" events="70" subjects_affected="58" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="54" subjects_affected="54" subjects_at_risk="826"/>
                <counts group_id="E2" events="58" subjects_affected="49" subjects_at_risk="822"/>
                <counts group_id="E3" events="59" subjects_affected="49" subjects_at_risk="824"/>
                <counts group_id="E4" events="50" subjects_affected="48" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="42" subjects_affected="38" subjects_at_risk="826"/>
                <counts group_id="E2" events="31" subjects_affected="29" subjects_at_risk="822"/>
                <counts group_id="E3" events="51" subjects_affected="46" subjects_at_risk="824"/>
                <counts group_id="E4" events="45" subjects_affected="42" subjects_at_risk="825"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="57" subjects_affected="53" subjects_at_risk="826"/>
                <counts group_id="E2" events="54" subjects_affected="46" subjects_at_risk="822"/>
                <counts group_id="E3" events="53" subjects_affected="38" subjects_at_risk="824"/>
                <counts group_id="E4" events="45" subjects_affected="38" subjects_at_risk="825"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="77" subjects_affected="54" subjects_at_risk="826"/>
                <counts group_id="E2" events="89" subjects_affected="58" subjects_at_risk="822"/>
                <counts group_id="E3" events="114" subjects_affected="67" subjects_at_risk="824"/>
                <counts group_id="E4" events="110" subjects_affected="74" subjects_at_risk="825"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Microalbuminuria</sub_title>
                <counts group_id="E1" events="30" subjects_affected="27" subjects_at_risk="826"/>
                <counts group_id="E2" events="35" subjects_affected="33" subjects_at_risk="822"/>
                <counts group_id="E3" events="51" subjects_affected="46" subjects_at_risk="824"/>
                <counts group_id="E4" events="45" subjects_affected="42" subjects_at_risk="825"/>
              </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="41" subjects_affected="36" subjects_at_risk="826"/>
                <counts group_id="E2" events="33" subjects_affected="32" subjects_at_risk="822"/>
                <counts group_id="E3" events="41" subjects_affected="40" subjects_at_risk="824"/>
                <counts group_id="E4" events="48" subjects_affected="46" subjects_at_risk="825"/>
              </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>At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Global Clinical Registry (GCR, 1452)</name_or_title>
      <organization>Novo Nordisk A/S</organization>
      <email>clinicaltrials@novonordisk.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01720446
org study id: NN9535-3744
secondary id: 2012-002839-28
secondary id: U1111-1131-7227
nct id: NCT01720446
lead sponsor: 
has dmc: No
This trial is conducted globally. The aim of the trial is to evaluate cardiovascular and
      other long-term outcomes with semaglutide in subjects with type 2 diabetes. The trial is
      event-driven, i.e. the maximum trial duration (up to max. 148 weeks) will depend on the
      accrual of major adverse cardiovascular events (MACE) in this trial and the remaining
      research programme. The incidence of MACE will be monitored throughout the trial which will
      be terminated according to plan when pre-specified stopping criteria are met.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Time From Randomisation to First Occurrence of a MACE, Defined as Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke
time frame: Time from randomisation up to end of follow-up (scheduled at week 109)
description: Percentage of subjects experiencing a first event of a major adverse cardiovascular event (MACE), defined as cardiovascular (CV) death, non-fatal myocardial infarction (MI), or non-fatal stroke.
measure: Time From Randomisation to First Occurrence of an Expanded Composite Cardiovascular Outcome
time frame: Time from randomisation up to end of follow-up (scheduled at week 109)
description: Percentage of subjects experiencing first occurrence of an expanded composite CV outcome (defined as either MACE, revascularisation [coronary and peripheral], unstable angina requiring hospitalisation or hospitalisation for heart failure)
measure: Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome
time frame: Time from randomisation up to end of follow-up (scheduled at week 109)
description: Percentage of subjects experiencing an event onset for each individual component of the expanded composite cardiovascular outcomes (defined as either MACE, revascularisation [coronary and peripheral], unstable angina requiring hospitalisation or hospitalisation for heart failure).
measure: Time From Randomisation to First Occurrence of All-cause Death, Non-fatal MI, or Non-fatal Stroke
time frame: Time from randomisation up to end of follow-up (scheduled at week 109)
description: Percentage of subjects experiencing a first occurrence of all-cause death, non-fatal MI, or non-fatal stroke.
measure: Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Glycosylated Haemoglobin (HbA1c)
time frame: Week 0, up to week 104
description: Estimated mean change from baseline in glycosylated haemoglobin (HbA1c) to last assessment in the trial during the treatment period.
measure: Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Fasting Plasma Glucose
time frame: Week 0, up to week 104
description: Estimated mean change from baseline to last assessment in fasting plasma glucose in the trial during the treatment period.
measure: Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Body Weight
time frame: Week 0, up to week 104
description: Estimated mean change from baseline to last assessment in body weight in the trial during the treatment period.
measure: Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Lipid Profile
time frame: Week 0, up to week 104
description: Estimated ratio to baseline at week 104 during the treatment period in lipid profile (total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides).
measure: Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Urinary Albumin to Creatinine Ratio
time frame: Week 0, up to week 104
description: Estimated ratio to baseline in urinary albumin to creatinine ratio at week 104 during the treatment period.
measure: Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Vital Signs
time frame: Week 0, up to week 104
description: Estimated mean change from baseline to last assessment in the trial during the treatment period in vital signs (diastolic blood pressure and systolic blood pressure).
measure: Incidence During the Trial in Other Treatment Outcomes: Hypoglycaemic Events
time frame: Week 0 - 109
description: Rates (event rate per 100 exposure years) of severe or blood glucose confirmed symptomatic hypoglycaemia defned as an episode that was severe according to the American diabetic association (ADA) classification or blood glucose (BG) confirmed by a PG value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
measure: Incidence During the Trial in Other Treatment Outcomes: Adverse Events
time frame: Weeks 0-109
description: Rates (event rate per 100 years of exposure) of treatment emergent adverse events.
measure: Occurrence During the Trial in Other Treatment Outcomes: Anti-semaglutide Antibodies
time frame: Weeks 0-109
description: The percentage of subjects that tested positive for anti-semaglutide antibodies at any time point post-baseline during the trial, from week 0 to week 109.
measure: Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Patient Reported Outcome (PRO)
time frame: Week 0, up to week 104
description: Estimated mean change from baseline to last assessment in the trial in patient reported outcomes (PRO). PRO questionnaire (SF-36v2TM) measured the individual overall health related quality of life namely bodily pain, general health, mental component summary, mental health, physical component summary, physical functioning, role-emotional, role-physical, social functioning and vitality. The PRO scores were transformed to a 0-100 scale with higher scores indicating greater health related quality of life.
measure: Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Lipid Profile (Free Fatty Acids)
time frame: Week 0, up to week 104
description: Estimated ratio to baseline at week 104 during the treatment period in lipid profile (free fatty acids).
measure: Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Vital Signs (Pulse Rate)
time frame: Week 0, up to week 104
description: Estimated mean change from baseline to last assessment in the trial during the treatment period in vital signs (pulse rate).
arm group label: Semaglutide 0.5 mg
arm group type: Experimental
arm group label: Semaglutide 1.0 mg
arm group type: Experimental
arm group label: Semaglutide placebo 0.5 mg
arm group type: Placebo Comparator
arm group label: Semaglutide placebo 1.0 mg
arm group type: Placebo Comparator
intervention type: Drug
intervention name: semaglutide
description: Once weekly doses of 0.5 mg semaglutide after an initial dose escalation step of 0.25 mg as an add-on to the standard-of-care treatment. Administered subcutaneously (s.c., under the skin)
arm group label: Semaglutide 0.5 mg
intervention type: Drug
intervention name: semaglutide
description: Once weekly doses of 1.0 mg semaglutide after an initial dose escalation step of 0.25 mg followed by 0.5 mg dose escalation as an add-on to the standard-of-care treatment. Administered subcutaneously (s.c., under the skin)
arm group label: Semaglutide 1.0 mg
intervention type: Drug
intervention name: placebo
description: Once weekly doses volume-matched placebo, as an add-on to the standard-of-care treatment. Administered subcutaneously (s.c., under the skin).
arm group label: Semaglutide placebo 0.5 mg
arm group label: Semaglutide placebo 1.0 mg
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Global Clinical Registry (GCR, 1452)
role: Study Director
affiliation: Novo Nordisk A/S
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country: Algeria
country: Argentina
country: Australia
country: Brazil
country: Bulgaria
country: Canada
country: Denmark
country: Germany
country: India
country: Israel
country: Italy
country: Malaysia
country: Mexico
country: Poland
country: Russian Federation
country: Spain
country: Taiwan
country: Thailand
country: Turkey
country: United Kingdom
country: United States
url: http://novonordisk-trials.com
description: Clinical Trials at Novo Nordisk
citation: Verma S, Bain SC, Monk Fries T, Mazer CD, Nauck MA, Pratley RE, Rasmussen S, Saevereid HA, Zinman B, Buse JB. Duration of diabetes and cardiorenal efficacy of liraglutide and semaglutide: A post hoc analysis of the LEADER and SUSTAIN 6 clinical trials. Diabetes Obes Metab. 2019 Jul;21(7):1745-1751. doi: 10.1111/dom.13698. Epub 2019 Apr 2.
PMID: 30851070
citation: Marso SP, Bain SC, Consoli A, Eliaschewitz FG, Jodar E, Leiter LA, Lingvay I, Rosenstock J, Seufert J, Warren ML, Woo V, Hansen O, Holst AG, Pettersson J, Vilsboll T; SUSTAIN-6 Investigators. Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. N Engl J Med. 2016 Nov 10;375(19):1834-1844. doi: 10.1056/NEJMoa1607141. Epub 2016 Sep 15.
PMID: 27633186
citation: Vilsboll T, Bain SC, Leiter LA, Lingvay I, Matthews D, Simo R, Helmark IC, Wijayasinghe N, Larsen M. Semaglutide, reduction in glycated haemoglobin and the risk of diabetic retinopathy. Diabetes Obes Metab. 2018 Apr;20(4):889-897. doi: 10.1111/dom.13172. Epub 2018 Jan 8.
PMID: 29178519
citation: Carlsson Petri KC, Ingwersen SH, Flint A, Zacho J, Overgaard RV. Semaglutide s.c. Once-Weekly in Type 2 Diabetes: A Population Pharmacokinetic Analysis. Diabetes Ther. 2018 Aug;9(4):1533-1547. doi: 10.1007/s13300-018-0458-5. Epub 2018 Jun 15.
PMID: 29907893
citation: Aroda VR, Ahmann A, Cariou B, Chow F, Davies MJ, Jodar E, Mehta R, Woo V, Lingvay I. Comparative efficacy, safety, and cardiovascular outcomes with once-weekly subcutaneous semaglutide in the treatment of type 2 diabetes: Insights from the SUSTAIN 1-7 trials. Diabetes Metab. 2019 Oct;45(5):409-418. doi: 10.1016/j.diabet.2018.12.001. Epub 2019 Jan 4.
PMID: 30615985
citation: Leiter LA, Bain SC, Hramiak I, Jodar E, Madsbad S, Gondolf T, Hansen T, Holst I, Lingvay I. Cardiovascular risk reduction with once-weekly semaglutide in subjects with type 2 diabetes: a post hoc analysis of gender, age, and baseline CV risk profile in the SUSTAIN 6 trial. Cardiovasc Diabetol. 2019 Jun 6;18(1):73. doi: 10.1186/s12933-019-0871-8.
PMID: 31167654
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
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