<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/NCT01703208</url>
  </required_header>
  <id_info>
    <org_study_id>3102-018</org_study_id>
    <secondary_id>2012-002414-39</secondary_id>
    <secondary_id>MK-3102-018</secondary_id>
    <nct_id>NCT01703208</nct_id>
  </id_info>
  <brief_title>A Study to Assess Cardiovascular Outcomes Following Treatment With Omarigliptin (MK-3102) in Participants With Type 2 Diabetes Mellitus (MK-3102-018)</brief_title>
  <official_title>A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess Cardiovascular Outcomes Following Treatment With MK-3102 in Subjects With Type 2 Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Merck Sharp &amp; Dohme LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the cardiovascular (CV) safety profile of&#xD;
      omarigliptin in participants with type 2 diabetes mellitus (T2DM). The primary hypothesis is&#xD;
      that treatment with omarigliptin 25 mg once weekly is non-inferior to treatment with placebo&#xD;
      and active comparators across the omarigliptin program with regard to the risk of developing&#xD;
      a confirmed event in the primary CV composite endpoint.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The trial was amended to extend the length of the trial in order to meet FDA requirements for&#xD;
      the post-approval assessment of cardiovascular (CV) safety. The trial now contains 2 time&#xD;
      intervals: Period 1 and Period 2. Period 1 refers to the time interval up to this recent&#xD;
      protocol amendment and Period 2, the time interval from this protocol amendment until the end&#xD;
      of the study. Participants in Period 1 will be re-consented and continue into Period 2. If&#xD;
      required, additional participants will be enrolled in Period 2. Stage 1 refers to the&#xD;
      prefiling United States Food and Drug Administration (US FDA) requirement to rule out a 80%&#xD;
      increased CV risk. Stage 2 refers to the US FDA post-marketing requirement to rule out a 30%&#xD;
      increased CV risk. The Stage 1 assessment of CV risk occurred during Period 1 and was based&#xD;
      on a meta-analysis of major adverse CV events (MACE) and unstable angina across the&#xD;
      omarigliptin Phase 2/Phase 3 program. The Stage 2 assessment will be based on MACE in P018&#xD;
      alone including CV events from both Period 1 and Period 2.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The study was terminated for business reasons and not due to any safety or efficacy concerns&#xD;
    related to omarigliptin&#xD;
  </why_stopped>
  <start_date type="Actual">October 5, 2012</start_date>
  <completion_date type="Actual">March 22, 2017</completion_date>
  <primary_completion_date type="Actual">May 13, 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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With MACE-plus (Confirmed Cardiovascular [CV]-Related Death, Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, or Hospitalization Due to Unstable Angina)</measure>
    <time_frame>Up to 156 weeks</time_frame>
    <description>Participants with confirmed MACE-plus events (confirmed cardiovascular, CV-related death, nonfatal myocardial infarction [MI], nonfatal stroke, or hospitalization due to unstable angina). In the MK-3102-018 study, MACE plus events had a data cut-off date of April 15, 2015.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With an Event of MACE (Confirmed CV-Related Death, Fatal and Nonfatal MI, and Fatal and Nonfatal Stroke)</measure>
    <time_frame>Up to 179 weeks</time_frame>
    <description>Participants with an Event of MACE (confirmed cardiovascular, CV-related death, fatal and nonfatal myocardial infarction [MI], and fatal and nonfatal stroke).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With an Event Per 100 Person-Years for First Event of MACE (Confirmed CV-Related Death, Fatal and Nonfatal MI, and Fatal and Nonfatal Stroke)</measure>
    <time_frame>Up to 179 weeks</time_frame>
    <description>Participants with an event of MACE (confirmed cardiovascular, CV-related death, fatal and nonfatal myocardial infarction [MI], and fatal and nonfatal stroke). Person-years were calculated as the sum of all participants' follow-up time to first event.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Hemoglobin A1C (A1C) at Week 18</measure>
    <time_frame>Baseline and Week 18</time_frame>
    <description>A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 18 A1C minus the Week 0 A1C.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in A1C at Week 18 in a Sub-Study of Participants Taking Insulin (With or Without Metformin)</measure>
    <time_frame>Baseline and Week 18</time_frame>
    <description>A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 18 A1C minus the Week 0 A1C.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Experienced at Least One Adverse Event in a Sub-study of Participants Taking Insulin Excluding Data After Background Antihyperglycemic Agent (AHA) Change</measure>
    <time_frame>Up to Week 18</time_frame>
    <description>An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Discontinued From Study Drug Due to an Adverse Event in a Sub-Study of Participants Taking Insulin Excluding Data After Background AHA Change</measure>
    <time_frame>Up to Week 18</time_frame>
    <description>An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With an Event of CV-Related Death</measure>
    <time_frame>Up to 179 weeks</time_frame>
    <description>Participants with adjudicated and confirmed AEs of cardiovascular-related death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With an Event Per 100 Person-Years of CV-Related Death</measure>
    <time_frame>Up to 179 weeks</time_frame>
    <description>Participants with adjudicated and confirmed AEs of cardiovascular-related death. Person-years were calculated as the sum of all participants' follow-up time to event.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With an Event of First MI (Fatal and Non-fatal)</measure>
    <time_frame>Up to 179 weeks</time_frame>
    <description>Participants with adjudicated and confirmed AEs of fatal and non-fatal MI.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With an Event Per 100 Person-Years of First MI (Fatal and Non-fatal)</measure>
    <time_frame>Up to 179 weeks</time_frame>
    <description>Participants with adjudicated and confirmed AEs of fatal and non-fatal MI. Person-years were calculated as the sum of all participants' follow-up time to first event.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With an Event of Stroke (Fatal and Non-fatal)</measure>
    <time_frame>Up to 179 weeks</time_frame>
    <description>Participants with adjudicated and confirmed AEs fatal and non-fatal stroke.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With an Event Per 100 Person-Years of First Stroke (Fatal and Non-fatal)</measure>
    <time_frame>Up to 179 weeks</time_frame>
    <description>Participants with adjudicated and confirmed AEs fatal and non-fatal stroke. Person-years were calculated as the sum of all participants' follow-up time to event.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With an Event of All-Cause Death</measure>
    <time_frame>Up to 179 weeks</time_frame>
    <description>All-cause death was death from any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With an Event Per 100 Person-Years of the Event of All-Cause Death</measure>
    <time_frame>Up to 179 weeks</time_frame>
    <description>All-cause death was death for any cause. Person-years were calculated as the sum of all participants' follow-up time to event.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in A1C at Week 142</measure>
    <time_frame>Baseline and Week 142</time_frame>
    <description>A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 142 A1C minus the Week 0 A1C.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving a Target A1C &lt;7.0 % (53 mmol/Mol) at 4 Months</measure>
    <time_frame>4 months</time_frame>
    <description>A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Fasting Plasma Glucose (FPG) at 4 Months</measure>
    <time_frame>Baseline and 4 months</time_frame>
    <description>This change from baseline reflects the Month 4 FPG minus the Week 0 FPG.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Initiation of Long-Term Insulin Therapy in Participants Not Receiving Insulin at Baseline</measure>
    <time_frame>Up to 179 weeks</time_frame>
    <description>Long-term insulin therapy was defined as a continuous period of insulin use of more than 3 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Experienced at Least One Adverse Event</measure>
    <time_frame>Up to 234 weeks</time_frame>
    <description>An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Discontinued From Study Drug Due to an Adverse Event</measure>
    <time_frame>Up to 212 weeks</time_frame>
    <description>An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in FPG at Week 18 in a Sub-Study of Participants Taking Insulin</measure>
    <time_frame>Baseline and Week 18</time_frame>
    <description>This change from baseline reflects the Week 18 FPG minus the Week 0 FPG.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving a Target A1C &lt;7.0 % (53 mmol/Mol) at Week 18 in a Sub-Study of Participants Taking Insulin</measure>
    <time_frame>18 weeks</time_frame>
    <description>A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Analysis was performed with multiple data imputation.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of Participants With an Event of First Hospitalization for Heart Failure (Exploratory)</measure>
    <time_frame>Up to 179 weeks</time_frame>
    <description>Participants with adjudicated and confirmed events of first hospitalization for heart failure.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With an Event Per 100 Person-years of the Event of the First Hospitalization for Heart Failure (Exploratory)</measure>
    <time_frame>Up to 179 weeks</time_frame>
    <description>Participants with adjudicated and confirmed events of first hospitalization for heart failure. Person-years were calculated as the sum of all participants' follow-up time to event.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">4202</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Omarigliptin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matching placebo to omarigliptin capsule or tablet administered orally once weekly</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Omarigliptin</intervention_name>
    <description>Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly</description>
    <arm_group_label>Omarigliptin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Matching placebo to omarigliptin capsule or tablet administered orally once weekly</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with type 2 diabetes mellitus&#xD;
&#xD;
          -  Is on one of the following diabetes treatment regimens that is stable for at least 12&#xD;
             weeks (except for pioglitazone for at least 16 weeks) and is within the associated A1C&#xD;
             range for that treatment regimen:&#xD;
&#xD;
               1. A1C &gt;= 6.5% and &lt;= 10.0% (&gt;=48 mmol/mol and &lt;=86 mmol/mol) on: (a) diet or&#xD;
                  exercise alone (not on antihyperglycemic agent [AHA] for &gt;= 12 weeks) OR (b)&#xD;
                  monotherapy with metformin (MF), pioglitazone (PIO) or an alpha-glucosidase&#xD;
                  inhibitor (AGI) or a sodium-glucose cotransporter inhibitor (SGLT2i) OR (c) dual&#xD;
                  combination therapy with MF, PIO, AGI or SGLT2i OR&#xD;
&#xD;
               2. A1C &gt;= 7.0% and &lt;=10.0% (&gt;=53 mmol/mol and &lt;=86 mmol/mol) on (a) monotherapy with&#xD;
                  a sulfonylurea or meglitinide OR (b) dual combination therapy with a sulfonylurea&#xD;
                  or a meglitinide and MF, PIO, AGI, or SGLT2i OR&#xD;
&#xD;
               3. A1C &gt;=7.0% and &lt;=10.0% (&gt;=53 mmol/mol and &lt;=86 mmol/mol) on one of the following&#xD;
                  insulin regimens (with or without metformin): (a) basal insulin (e.g.; insulin&#xD;
                  glargine, insulin detemir, NPH insulin, degludec) OR (b) prandial insulin (e.g.&#xD;
                  regular, aspart, lispro, glulisine) OR (c) basal/prandial insulin regimen&#xD;
                  consisting of multiple dose insulin injections of basal and prandial insulin or&#xD;
                  the use of pre-mixed insulin (e.g., Novolog 70/30®, Novolin 70/30®, Humalog&#xD;
                  75/25®, or Humulin 70/30®&#xD;
&#xD;
          -  Pre-existing vascular disease (coronary artery disease, ischemic cerebrovascular&#xD;
             disease, atherosclerotic peripheral artery disease)&#xD;
&#xD;
          -  (1) Male; (2) female not of reproductive potential; or (3) female of reproductive&#xD;
             potential who agrees to remain abstinent or use alone or in conjunction with their&#xD;
             partner 2 methods of contraception to prevent pregnancy during the study and for 21&#xD;
             days after the last dose of study drug.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of type 1 diabetes mellitus or a history of ketoacidosis&#xD;
&#xD;
          -  Treated with rosiglitazone, a dipeptidyl peptidase-IV (DPP-4) inhibitor, or a&#xD;
             glucagon-like peptide-1 (GLP-1) receptor agonist within 12 weeks prior to study&#xD;
             participation or previously treated with omarigliptin&#xD;
&#xD;
          -  On a weight loss program and is not in the maintenance phase or has been on a weight&#xD;
             loss medication in the past 6 months or has undergone bariatric surgery within 12&#xD;
             months prior to study participation&#xD;
&#xD;
          -  Medical history of active liver disease (other than non-alcoholic hepatic steatosis),&#xD;
             including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic&#xD;
             gallbladder disease&#xD;
&#xD;
          -  Human immunodeficiency virus (HIV) as assessed by medical history&#xD;
&#xD;
          -  New or worsening coronary heart disease, congestive heart failure, myocardial&#xD;
             infarction, unstable angina, coronary artery intervention, stroke, or transient&#xD;
             ischemic neurological disorder within the past 3 months&#xD;
&#xD;
          -  History of malignancy &lt;=5 years prior to study participation, except for adequately&#xD;
             treated basal cell or squamous cell skin cancer, or in situ cervical cancer&#xD;
&#xD;
          -  Clinically important hematological disorder (such as aplastic anemia,&#xD;
             myeloproliferative or myelodysplastic syndromes, thrombocytopenia)&#xD;
&#xD;
          -  Pregnant or breast feeding, or is expecting to conceive or donate eggs during the&#xD;
             trial, including 21 days following the last dose of study drug&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Merck Sharp &amp; Dohme LLC</affiliation>
  </overall_official>
  <removed_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Brazil</country>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>Chile</country>
    <country>Colombia</country>
    <country>Croatia</country>
    <country>Czech Republic</country>
    <country>Denmark</country>
    <country>Finland</country>
    <country>France</country>
    <country>Georgia</country>
    <country>Germany</country>
    <country>Hong Kong</country>
    <country>Hungary</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Korea, Republic of</country>
    <country>Lebanon</country>
    <country>Lithuania</country>
    <country>Malaysia</country>
    <country>Mexico</country>
    <country>Netherlands</country>
    <country>New Zealand</country>
    <country>Philippines</country>
    <country>Poland</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>Serbia</country>
    <country>Slovakia</country>
    <country>South Africa</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Taiwan</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </removed_countries>
  <results_reference>
    <citation>Gantz I, Chen M, Suryawanshi S, Ntabadde C, Shah S, O'Neill EA, Engel SS, Kaufman KD, Lai E. A randomized, placebo-controlled study of the cardiovascular safety of the once-weekly DPP-4 inhibitor omarigliptin in patients with type 2 diabetes mellitus. Cardiovasc Diabetol. 2017 Sep 11;16(1):112. doi: 10.1186/s12933-017-0593-8.</citation>
    <PMID>28893244</PMID>
  </results_reference>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>October 5, 2012</study_first_submitted>
  <study_first_submitted_qc>October 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2012</study_first_posted>
  <results_first_submitted>November 13, 2017</results_first_submitted>
  <results_first_submitted_qc>November 13, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">December 12, 2017</results_first_posted>
  <last_update_submitted>October 10, 2018</last_update_submitted>
  <last_update_submitted_qc>October 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 6, 2018</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>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf</ipd_description>
    <ipd_url>http://engagezone.msd.com/ds_documentation.php</ipd_url>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 559 sites received IEC/IRB approval in 40 countries and 547 were shipped clinical supplies. Of the 559 sites, 525 screened at least 1 participant.&#xD;
An insulin sub-study of MK-3102-018 was performed and included the sub-population of participants receiving ≥20 units/day of background insulin with or without metformin.</recruitment_details>
      <pre_assignment_details>On April 8, 2016, Merck &amp; Co. Inc. announced that it would not submit marketing applications for omarigliptin (MK-3102) in the US and Europe for business reasons only. Because of this decision, the MK-3102-018 study was terminated early on May 13, 2016. Due to delays in study close-out the Last-Participant-Last-Visit occurred on March 22, 2017.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Omarigliptin 25 mg</title>
          <description>Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Matching placebo to omarigliptin capsule or tablet administered once weekly.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2100"/>
                <participants group_id="P2" count="2102"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="2092"/>
                <participants group_id="P2" count="2100"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2100"/>
                <participants group_id="P2" count="2102"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="61"/>
                <participants group_id="P2" count="48"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="68"/>
                <participants group_id="P2" count="62"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-Compliance with Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Excluded Medication</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Site Discontinued Study Participation</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="27"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Progressive disease</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study Terminated by Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="1710"/>
                <participants group_id="P2" count="1716"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="205"/>
                <participants group_id="P2" count="209"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Technical Problems</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Deviation</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Omarigliptin 25 mg</title>
          <description>Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Matching placebo to omarigliptin capsule or tablet administered once weekly.</description>
        </group>
        <group group_id="B3">
          <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="2100"/>
            <count group_id="B2" value="2102"/>
            <count group_id="B3" value="4202"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63.7" spread="8.5"/>
                    <measurement group_id="B2" value="63.6" spread="8.5"/>
                    <measurement group_id="B3" value="63.6" spread="8.5"/>
                  </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="639"/>
                    <measurement group_id="B2" value="615"/>
                    <measurement group_id="B3" value="1254"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1461"/>
                    <measurement group_id="B2" value="1487"/>
                    <measurement group_id="B3" value="2948"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hemoglobin A1C %</title>
          <description>Hemoglobin A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%).</description>
          <units>Percent</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.99" spread="0.86"/>
                    <measurement group_id="B2" value="8.03" spread="0.89"/>
                    <measurement group_id="B3" value="8.01" spread="0.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Fasting Plasma Glucose (FPG)</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="184.1" spread="52.2"/>
                    <measurement group_id="B2" value="179.5" spread="45.7"/>
                    <measurement group_id="B3" value="180.4" spread="47.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With MACE-plus (Confirmed Cardiovascular [CV]-Related Death, Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, or Hospitalization Due to Unstable Angina)</title>
        <description>Participants with confirmed MACE-plus events (confirmed cardiovascular, CV-related death, nonfatal myocardial infarction [MI], nonfatal stroke, or hospitalization due to unstable angina). In the MK-3102-018 study, MACE plus events had a data cut-off date of April 15, 2015.</description>
        <time_frame>Up to 156 weeks</time_frame>
        <population>The analysis population included all randomized participants who took at least one dose of blinded study medication and were evaluated for MACE-plus events.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin 25 mg</title>
            <description>Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Matching placebo to omarigliptin capsule or tablet administered once weekly.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With MACE-plus (Confirmed Cardiovascular [CV]-Related Death, Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, or Hospitalization Due to Unstable Angina)</title>
          <description>Participants with confirmed MACE-plus events (confirmed cardiovascular, CV-related death, nonfatal myocardial infarction [MI], nonfatal stroke, or hospitalization due to unstable angina). In the MK-3102-018 study, MACE plus events had a data cut-off date of April 15, 2015.</description>
          <population>The analysis population included all randomized participants who took at least one dose of blinded study medication and were evaluated for MACE-plus events.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2090"/>
                <count group_id="O2" value="2100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66" lower_limit="-1.14" upper_limit="-0.90"/>
                    <measurement group_id="O2" value="70" lower_limit="-1.20" upper_limit="-0.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With an Event of MACE (Confirmed CV-Related Death, Fatal and Nonfatal MI, and Fatal and Nonfatal Stroke)</title>
        <description>Participants with an Event of MACE (confirmed cardiovascular, CV-related death, fatal and nonfatal myocardial infarction [MI], and fatal and nonfatal stroke).</description>
        <time_frame>Up to 179 weeks</time_frame>
        <population>The analysis population included all randomized participants who took at least one dose of blinded trial medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin 25 mg</title>
            <description>Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Matching placebo to omarigliptin capsule or tablet administered once weekly.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With an Event of MACE (Confirmed CV-Related Death, Fatal and Nonfatal MI, and Fatal and Nonfatal Stroke)</title>
          <description>Participants with an Event of MACE (confirmed cardiovascular, CV-related death, fatal and nonfatal myocardial infarction [MI], and fatal and nonfatal stroke).</description>
          <population>The analysis population included all randomized participants who took at least one dose of blinded trial medication.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2092"/>
                <count group_id="O2" value="2100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="114" lower_limit="-1.14" upper_limit="-0.90"/>
                    <measurement group_id="O2" value="114" lower_limit="-1.20" upper_limit="-0.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With an Event Per 100 Person-Years for First Event of MACE (Confirmed CV-Related Death, Fatal and Nonfatal MI, and Fatal and Nonfatal Stroke)</title>
        <description>Participants with an event of MACE (confirmed cardiovascular, CV-related death, fatal and nonfatal myocardial infarction [MI], and fatal and nonfatal stroke). Person-years were calculated as the sum of all participants' follow-up time to first event.</description>
        <time_frame>Up to 179 weeks</time_frame>
        <population>The analysis population included all randomized participants who took at least one dose of blinded trial medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin 25 mg</title>
            <description>Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Matching placebo to omarigliptin capsule or tablet administered once weekly.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With an Event Per 100 Person-Years for First Event of MACE (Confirmed CV-Related Death, Fatal and Nonfatal MI, and Fatal and Nonfatal Stroke)</title>
          <description>Participants with an event of MACE (confirmed cardiovascular, CV-related death, fatal and nonfatal myocardial infarction [MI], and fatal and nonfatal stroke). Person-years were calculated as the sum of all participants' follow-up time to first event.</description>
          <population>The analysis population included all randomized participants who took at least one dose of blinded trial medication.</population>
          <units>Participants/100 Person-years</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2092"/>
                <count group_id="O2" value="2100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.96" lower_limit="-1.14" upper_limit="-0.90"/>
                    <measurement group_id="O2" value="2.97" lower_limit="-1.20" upper_limit="-0.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.77</ci_lower_limit>
            <ci_upper_limit>1.29</ci_upper_limit>
            <estimate_desc>Based on the proportional hazards model that includes treatment as an explanatory factor.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Hemoglobin A1C (A1C) at Week 18</title>
        <description>A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 18 A1C minus the Week 0 A1C.</description>
        <time_frame>Baseline and Week 18</time_frame>
        <population>The analysis population consisted of all randomized participants who received at least one dose of blinded study medication and had a baseline or a post-randomization measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin 25 mg</title>
            <description>Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Matching placebo to omarigliptin capsule or tablet administered once weekly.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Hemoglobin A1C (A1C) at Week 18</title>
          <description>A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 18 A1C minus the Week 0 A1C.</description>
          <population>The analysis population consisted of all randomized participants who received at least one dose of blinded study medication and had a baseline or a post-randomization measurement.</population>
          <units>Percent</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2092"/>
                <count group_id="O2" value="2100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.58" spread="0.82" lower_limit="-0.62" upper_limit="-0.55"/>
                    <measurement group_id="O2" value="-0.16" spread="0.88" lower_limit="-0.19" upper_limit="-0.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in the least squares means</param_type>
            <param_value>-0.43</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>-0.37</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in A1C at Week 18 in a Sub-Study of Participants Taking Insulin (With or Without Metformin)</title>
        <description>A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 18 A1C minus the Week 0 A1C.</description>
        <time_frame>Baseline and Week 18</time_frame>
        <population>The analysis population consists of all randomized participants in a sub-study of participants taking insulin who received at least one dose of blinded study medication and had a baseline or a post-randomization measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin 25 mg</title>
            <description>Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Matching placebo to omarigliptin capsule or tablet administered once weekly.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in A1C at Week 18 in a Sub-Study of Participants Taking Insulin (With or Without Metformin)</title>
          <description>A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 18 A1C minus the Week 0 A1C.</description>
          <population>The analysis population consists of all randomized participants in a sub-study of participants taking insulin who received at least one dose of blinded study medication and had a baseline or a post-randomization measurement.</population>
          <units>Percentage</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="535"/>
                <count group_id="O2" value="509"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.50" lower_limit="-0.57" upper_limit="-0.42"/>
                    <measurement group_id="O2" value="-0.11" lower_limit="-0.19" upper_limit="-0.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Longitudinal data analysis</method>
            <method_desc>Longitudinal data analysis model including terms for treatment, time and the interaction of time by treatment.</method_desc>
            <param_type>Difference in the LS Means vs Placebo</param_type>
            <param_value>-0.39</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.50</ci_lower_limit>
            <ci_upper_limit>-0.27</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Experienced at Least One Adverse Event in a Sub-study of Participants Taking Insulin Excluding Data After Background Antihyperglycemic Agent (AHA) Change</title>
        <description>An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.</description>
        <time_frame>Up to Week 18</time_frame>
        <population>The analysis population included all randomized participants in a sub-study of participants taking insulin who received at least one dose of blinded study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin 25 mg</title>
            <description>Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Matching placebo to omarigliptin capsule or tablet administered once weekly.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Experienced at Least One Adverse Event in a Sub-study of Participants Taking Insulin Excluding Data After Background Antihyperglycemic Agent (AHA) Change</title>
          <description>An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.</description>
          <population>The analysis population included all randomized participants in a sub-study of participants taking insulin who received at least one dose of blinded study medication.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="535"/>
                <count group_id="O2" value="509"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.8"/>
                    <measurement group_id="O2" value="49.9"/>
                  </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>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in Percent vs. Placebo</param_type>
            <param_value>-1.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.2</ci_lower_limit>
            <ci_upper_limit>4.9</ci_upper_limit>
            <estimate_desc>Based on Miettinen &amp; Nurminen method. The 95% CI was computed only for those endpoints with at least 4 participants having events in one or more treatment groups.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Discontinued From Study Drug Due to an Adverse Event in a Sub-Study of Participants Taking Insulin Excluding Data After Background AHA Change</title>
        <description>An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.</description>
        <time_frame>Up to Week 18</time_frame>
        <population>The analysis population included all randomized participants in a sub-study of participants taking insulin who received at least one dose of blinded study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin 25 mg</title>
            <description>Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Matching placebo to omarigliptin capsule or tablet administered once weekly.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Discontinued From Study Drug Due to an Adverse Event in a Sub-Study of Participants Taking Insulin Excluding Data After Background AHA Change</title>
          <description>An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.</description>
          <population>The analysis population included all randomized participants in a sub-study of participants taking insulin who received at least one dose of blinded study medication.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="535"/>
                <count group_id="O2" value="509"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" lower_limit="-3.13" upper_limit="-2.25"/>
                    <measurement group_id="O2" value="0.8" lower_limit="-4.18" upper_limit="-3.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in Percentage vs. Placebo</param_type>
            <param_value>0.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.0</ci_lower_limit>
            <ci_upper_limit>1.7</ci_upper_limit>
            <estimate_desc>Based on Miettinen &amp; Nurminen method. The 95% CI was computed only for those endpoints with at least 4 participants having events in one or more treatment groups.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With an Event of CV-Related Death</title>
        <description>Participants with adjudicated and confirmed AEs of cardiovascular-related death.</description>
        <time_frame>Up to 179 weeks</time_frame>
        <population>The analysis population consisted of all randomized participants who received at least one dose of blinded study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin 25 mg</title>
            <description>Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Matching placebo to omarigliptin capsule or tablet administered once weekly.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With an Event of CV-Related Death</title>
          <description>Participants with adjudicated and confirmed AEs of cardiovascular-related death.</description>
          <population>The analysis population consisted of all randomized participants who received at least one dose of blinded study medication.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2092"/>
                <count group_id="O2" value="2100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37" lower_limit="-40.04" upper_limit="-31.42"/>
                    <measurement group_id="O2" value="35" lower_limit="-41.21" upper_limit="-32.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With an Event Per 100 Person-Years of CV-Related Death</title>
        <description>Participants with adjudicated and confirmed AEs of cardiovascular-related death. Person-years were calculated as the sum of all participants' follow-up time to event.</description>
        <time_frame>Up to 179 weeks</time_frame>
        <population>The analysis population consisted of all participants who took at least one dose of blinded study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin 25 mg</title>
            <description>Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Matching placebo to omarigliptin capsule or tablet administered once weekly.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With an Event Per 100 Person-Years of CV-Related Death</title>
          <description>Participants with adjudicated and confirmed AEs of cardiovascular-related death. Person-years were calculated as the sum of all participants' follow-up time to event.</description>
          <population>The analysis population consisted of all participants who took at least one dose of blinded study medication.</population>
          <units>Participants/100 person-years</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2092"/>
                <count group_id="O2" value="2100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.94" lower_limit="-40.04" upper_limit="-31.42"/>
                    <measurement group_id="O2" value="0.89" lower_limit="-41.21" upper_limit="-32.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.06</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.66</ci_lower_limit>
            <ci_upper_limit>1.68</ci_upper_limit>
            <estimate_desc>Based on the proportional hazards model that includes treatment as an explanatory factor.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With an Event of First MI (Fatal and Non-fatal)</title>
        <description>Participants with adjudicated and confirmed AEs of fatal and non-fatal MI.</description>
        <time_frame>Up to 179 weeks</time_frame>
        <population>The analysis population consisted of all participants who took at least one dose of blinded study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin 25 mg</title>
            <description>Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Matching placebo to omarigliptin capsule or tablet administered once weekly.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With an Event of First MI (Fatal and Non-fatal)</title>
          <description>Participants with adjudicated and confirmed AEs of fatal and non-fatal MI.</description>
          <population>The analysis population consisted of all participants who took at least one dose of blinded study medication.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2092"/>
                <count group_id="O2" value="2100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52" lower_limit="-40.04" upper_limit="-31.42"/>
                    <measurement group_id="O2" value="60" lower_limit="-41.21" upper_limit="-32.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With an Event Per 100 Person-Years of First MI (Fatal and Non-fatal)</title>
        <description>Participants with adjudicated and confirmed AEs of fatal and non-fatal MI. Person-years were calculated as the sum of all participants' follow-up time to first event.</description>
        <time_frame>Up to 179 weeks</time_frame>
        <population>The analysis population consisted of all participants who took at least one dose of blinded study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin 25 mg</title>
            <description>Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Matching placebo to omarigliptin capsule or tablet administered once weekly.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With an Event Per 100 Person-Years of First MI (Fatal and Non-fatal)</title>
          <description>Participants with adjudicated and confirmed AEs of fatal and non-fatal MI. Person-years were calculated as the sum of all participants' follow-up time to first event.</description>
          <population>The analysis population consisted of all participants who took at least one dose of blinded study medication.</population>
          <units>Participants/100 person-years</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2092"/>
                <count group_id="O2" value="2100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.34" lower_limit="-40.04" upper_limit="-31.42"/>
                    <measurement group_id="O2" value="1.55" lower_limit="-41.21" upper_limit="-32.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.87</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.60</ci_lower_limit>
            <ci_upper_limit>1.26</ci_upper_limit>
            <estimate_desc>Based on the proportional hazards model that includes treatment as an explanatory factor.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With an Event of Stroke (Fatal and Non-fatal)</title>
        <description>Participants with adjudicated and confirmed AEs fatal and non-fatal stroke.</description>
        <time_frame>Up to 179 weeks</time_frame>
        <population>The analysis population consisted of all participants who took at least one dose of blinded study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin 25 mg</title>
            <description>Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Matching placebo to omarigliptin capsule or tablet administered once weekly.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With an Event of Stroke (Fatal and Non-fatal)</title>
          <description>Participants with adjudicated and confirmed AEs fatal and non-fatal stroke.</description>
          <population>The analysis population consisted of all participants who took at least one dose of blinded study medication.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2092"/>
                <count group_id="O2" value="2100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32" lower_limit="-40.04" upper_limit="-31.42"/>
                    <measurement group_id="O2" value="34" lower_limit="-41.21" upper_limit="-32.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With an Event Per 100 Person-Years of First Stroke (Fatal and Non-fatal)</title>
        <description>Participants with adjudicated and confirmed AEs fatal and non-fatal stroke. Person-years were calculated as the sum of all participants' follow-up time to event.</description>
        <time_frame>Up to 179 weeks</time_frame>
        <population>The analysis population consisted of all participants who took at least one dose of blinded study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin 25 mg</title>
            <description>Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Matching placebo to omarigliptin capsule or tablet administered once weekly.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With an Event Per 100 Person-Years of First Stroke (Fatal and Non-fatal)</title>
          <description>Participants with adjudicated and confirmed AEs fatal and non-fatal stroke. Person-years were calculated as the sum of all participants' follow-up time to event.</description>
          <population>The analysis population consisted of all participants who took at least one dose of blinded study medication.</population>
          <units>Participants/100 person-years</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2092"/>
                <count group_id="O2" value="2100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.82" lower_limit="-40.04" upper_limit="-31.42"/>
                    <measurement group_id="O2" value="0.88" lower_limit="-41.21" upper_limit="-32.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.94</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.58</ci_lower_limit>
            <ci_upper_limit>1.52</ci_upper_limit>
            <estimate_desc>Based on the proportional hazards model that includes treatment as an explanatory factor.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With an Event of All-Cause Death</title>
        <description>All-cause death was death from any cause.</description>
        <time_frame>Up to 179 weeks</time_frame>
        <population>The analysis population included all randomized participants who took at least one dose of blinded trial medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin 25 mg</title>
            <description>Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Matching placebo to omarigliptin capsule or tablet administered once weekly.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With an Event of All-Cause Death</title>
          <description>All-cause death was death from any cause.</description>
          <population>The analysis population included all randomized participants who took at least one dose of blinded trial medication.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2092"/>
                <count group_id="O2" value="2100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64"/>
                    <measurement group_id="O2" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With an Event Per 100 Person-Years of the Event of All-Cause Death</title>
        <description>All-cause death was death for any cause. Person-years were calculated as the sum of all participants' follow-up time to event.</description>
        <time_frame>Up to 179 weeks</time_frame>
        <population>The analysis population included all randomized participants who took at least one dose of blinded study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin 25 mg</title>
            <description>Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Matching placebo to omarigliptin capsule or tablet administered once weekly.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With an Event Per 100 Person-Years of the Event of All-Cause Death</title>
          <description>All-cause death was death for any cause. Person-years were calculated as the sum of all participants' follow-up time to event.</description>
          <population>The analysis population included all randomized participants who took at least one dose of blinded study medication.</population>
          <units>Participants/100 Person-years</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2092"/>
                <count group_id="O2" value="2100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.63"/>
                    <measurement group_id="O2" value="1.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.28</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>1.85</ci_upper_limit>
            <estimate_desc>Based on the proportional hazards model that includes treatment as an explanatory factor.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in A1C at Week 142</title>
        <description>A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 142 A1C minus the Week 0 A1C.</description>
        <time_frame>Baseline and Week 142</time_frame>
        <population>The analysis population consisted of all randomized participants who received at least one dose of blinded study medication and had a baseline or a post-randomization measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin 25 mg</title>
            <description>Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Matching placebo to omarigliptin capsule or tablet administered once weekly.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in A1C at Week 142</title>
          <description>A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 142 A1C minus the Week 0 A1C.</description>
          <population>The analysis population consisted of all randomized participants who received at least one dose of blinded study medication and had a baseline or a post-randomization measurement.</population>
          <units>Percent</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2092"/>
                <count group_id="O2" value="2100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.36" spread="0.06" lower_limit="-0.47" upper_limit="-0.25"/>
                    <measurement group_id="O2" value="-0.06" spread="1.12" lower_limit="-0.17" upper_limit="0.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in the Least Squares Means</param_type>
            <param_value>-0.30</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.46</ci_lower_limit>
            <ci_upper_limit>-0.14</ci_upper_limit>
            <estimate_desc>Longitudinal Data Analysis (LDA) model including terms for treatment, time, and the interaction of time by treatment.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving a Target A1C &lt;7.0 % (53 mmol/Mol) at 4 Months</title>
        <description>A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%).</description>
        <time_frame>4 months</time_frame>
        <population>Data for this efficacy endpoint was not collected, analyzed or summarized.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin 25 mg</title>
            <description>Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Matching placebo to omarigliptin capsule or tablet administered once weekly.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving a Target A1C &lt;7.0 % (53 mmol/Mol) at 4 Months</title>
          <description>A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%).</description>
          <population>Data for this efficacy endpoint was not collected, analyzed or summarized.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Fasting Plasma Glucose (FPG) at 4 Months</title>
        <description>This change from baseline reflects the Month 4 FPG minus the Week 0 FPG.</description>
        <time_frame>Baseline and 4 months</time_frame>
        <population>Data for this efficacy endpoint was not collected, analyzed or summarized.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin 25 mg</title>
            <description>Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Matching placebo to omarigliptin capsule or tablet administered once weekly.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Fasting Plasma Glucose (FPG) at 4 Months</title>
          <description>This change from baseline reflects the Month 4 FPG minus the Week 0 FPG.</description>
          <population>Data for this efficacy endpoint was not collected, analyzed or summarized.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Initiation of Long-Term Insulin Therapy in Participants Not Receiving Insulin at Baseline</title>
        <description>Long-term insulin therapy was defined as a continuous period of insulin use of more than 3 months.</description>
        <time_frame>Up to 179 weeks</time_frame>
        <population>Data for this efficacy endpoint was not collected, analyzed or summarized.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin 25 mg</title>
            <description>Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Matching placebo to omarigliptin capsule or tablet administered once weekly.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Initiation of Long-Term Insulin Therapy in Participants Not Receiving Insulin at Baseline</title>
          <description>Long-term insulin therapy was defined as a continuous period of insulin use of more than 3 months.</description>
          <population>Data for this efficacy endpoint was not collected, analyzed or summarized.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Experienced at Least One Adverse Event</title>
        <description>An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.</description>
        <time_frame>Up to 234 weeks</time_frame>
        <population>The analysis population included all randomized participants who took at least one dose of blinded study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin 25 mg</title>
            <description>Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Matching placebo to omarigliptin capsule or tablet administered once weekly.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Experienced at Least One Adverse Event</title>
          <description>An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.</description>
          <population>The analysis population included all randomized participants who took at least one dose of blinded study medication.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2092"/>
                <count group_id="O2" value="2100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.3"/>
                    <measurement group_id="O2" value="76.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Discontinued From Study Drug Due to an Adverse Event</title>
        <description>An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.</description>
        <time_frame>Up to 212 weeks</time_frame>
        <population>The analysis population included all randomized participants who took at least one dose of blinded study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin 25 mg</title>
            <description>Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Matching placebo to omarigliptin capsule or tablet administered once weekly.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Discontinued From Study Drug Due to an Adverse Event</title>
          <description>An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.</description>
          <population>The analysis population included all randomized participants who took at least one dose of blinded study medication.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2092"/>
                <count group_id="O2" value="2100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.1"/>
                    <measurement group_id="O2" value="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in FPG at Week 18 in a Sub-Study of Participants Taking Insulin</title>
        <description>This change from baseline reflects the Week 18 FPG minus the Week 0 FPG.</description>
        <time_frame>Baseline and Week 18</time_frame>
        <population>The analysis population consisted of all randomized participants in a sub-study of participants taking insulin who received at least one dose of blinded study medication and had a baseline or a post-randomization measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin 25 mg</title>
            <description>Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Matching placebo to omarigliptin capsule or tablet administered once weekly.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in FPG at Week 18 in a Sub-Study of Participants Taking Insulin</title>
          <description>This change from baseline reflects the Week 18 FPG minus the Week 0 FPG.</description>
          <population>The analysis population consisted of all randomized participants in a sub-study of participants taking insulin who received at least one dose of blinded study medication and had a baseline or a post-randomization measurement.</population>
          <units>mg/dL</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="535"/>
                <count group_id="O2" value="509"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.8" lower_limit="-12.1" upper_limit="-1.5"/>
                    <measurement group_id="O2" value="-3.6" lower_limit="-9.1" upper_limit="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.421</p_value>
            <method>Longitudinal constrained data analysis</method>
            <param_type>Difference in the least squares means</param_type>
            <param_value>-3.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.8</ci_lower_limit>
            <ci_upper_limit>4.5</ci_upper_limit>
            <estimate_desc>Based on a LDA model including terms for treatment, time and the interaction of time by treatment.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving a Target A1C &lt;7.0 % (53 mmol/Mol) at Week 18 in a Sub-Study of Participants Taking Insulin</title>
        <description>A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Analysis was performed with multiple data imputation.</description>
        <time_frame>18 weeks</time_frame>
        <population>The analysis population consisted of all randomized participants in a sub-study of participants taking insulin who received at least one dose of blinded study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin 25 mg</title>
            <description>Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Matching placebo to omarigliptin capsule or tablet administered once weekly.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving a Target A1C &lt;7.0 % (53 mmol/Mol) at Week 18 in a Sub-Study of Participants Taking Insulin</title>
          <description>A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Analysis was performed with multiple data imputation.</description>
          <population>The analysis population consisted of all randomized participants in a sub-study of participants taking insulin who received at least one dose of blinded study medication.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="535"/>
                <count group_id="O2" value="509"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.0" lower_limit="18.5" upper_limit="26.1"/>
                    <measurement group_id="O2" value="10.2" lower_limit="7.5" upper_limit="13.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Estimated using standard multiple imputation techniques.</p_value_desc>
            <method>Miettinen &amp; Nurminen method</method>
            <param_type>Between group rate difference</param_type>
            <param_value>11.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>6.9</ci_lower_limit>
            <ci_upper_limit>16.8</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With an Event of First Hospitalization for Heart Failure (Exploratory)</title>
        <description>Participants with adjudicated and confirmed events of first hospitalization for heart failure.</description>
        <time_frame>Up to 179 weeks</time_frame>
        <population>The analysis population consisted of all participants who took at least one dose of blinded study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin 25 mg</title>
            <description>Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Matching placebo to omarigliptin capsule or tablet administered once weekly.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With an Event of First Hospitalization for Heart Failure (Exploratory)</title>
          <description>Participants with adjudicated and confirmed events of first hospitalization for heart failure.</description>
          <population>The analysis population consisted of all participants who took at least one dose of blinded study medication.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2092"/>
                <count group_id="O2" value="2100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With an Event Per 100 Person-years of the Event of the First Hospitalization for Heart Failure (Exploratory)</title>
        <description>Participants with adjudicated and confirmed events of first hospitalization for heart failure. Person-years were calculated as the sum of all participants' follow-up time to event.</description>
        <time_frame>Up to 179 weeks</time_frame>
        <population>The analysis population consisted of all participants who took at least one dose of blinded study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Omarigliptin 25 mg</title>
            <description>Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Matching placebo to omarigliptin capsule or tablet administered once weekly.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With an Event Per 100 Person-years of the Event of the First Hospitalization for Heart Failure (Exploratory)</title>
          <description>Participants with adjudicated and confirmed events of first hospitalization for heart failure. Person-years were calculated as the sum of all participants' follow-up time to event.</description>
          <population>The analysis population consisted of all participants who took at least one dose of blinded study medication.</population>
          <units>Participants/100 Person-years</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2092"/>
                <count group_id="O2" value="2100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.51"/>
                    <measurement group_id="O2" value="0.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.60</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.35</ci_lower_limit>
            <ci_upper_limit>1.05</ci_upper_limit>
            <estimate_desc>Based on the proportional hazards model that includes treatment as an explanatory factor.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 234 weeks</time_frame>
      <desc>Participants with serious adverse events with an incidence &gt; 0% and with &gt;5% non-serous adverse events in one or more treatment groups during the Treatment Period + Post-Treatment Follow-up including Post-21 days after last dose of blinded study treatment for randomized participants receiving one or more doses of study treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>Omarigliptin 25 mg</title>
          <description>Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Matching placebo to omarigliptin capsule or tablet administered once weekly.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 19.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="512" subjects_at_risk="2092"/>
                <counts group_id="E2" subjects_affected="503" subjects_at_risk="2100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Agranulocytosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="2092"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Coagulation factor deficiency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Disseminated intravascular coagulation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Haemorrhagic anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Iron deficiency anaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Lymphadenitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Pancytopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Splenic infarction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Thrombocytosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2092"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="35" subjects_affected="30" subjects_at_risk="2092"/>
                <counts group_id="E2" events="28" subjects_affected="27" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="29" subjects_affected="27" subjects_at_risk="2092"/>
                <counts group_id="E2" events="36" subjects_affected="31" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" events="39" subjects_affected="33" subjects_at_risk="2092"/>
                <counts group_id="E2" events="46" subjects_affected="42" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Aortic valve stenosis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Arteriosclerosis coronary artery</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="14" subjects_affected="14" subjects_at_risk="2092"/>
                <counts group_id="E2" events="17" subjects_affected="16" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" events="7" subjects_affected="5" subjects_at_risk="2092"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Atrial tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Atrioventricular block</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Atrioventricular block complete</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Bradyarrhythmia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Cardiac aneurysm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="2092"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="21" subjects_affected="17" subjects_at_risk="2092"/>
                <counts group_id="E2" events="12" subjects_affected="12" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Cardiac failure acute</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="2092"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Cardiac failure chronic</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="2092"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" events="16" subjects_affected="14" subjects_at_risk="2092"/>
                <counts group_id="E2" events="25" subjects_affected="20" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Cardio-respiratory arrest</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Cardiogenic shock</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Cardiomyopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Cardiopulmonary failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Conduction disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Cor pulmonale</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="24" subjects_affected="22" subjects_at_risk="2092"/>
                <counts group_id="E2" events="24" subjects_affected="23" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Coronary artery insufficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Coronary artery occlusion</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2092"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Coronary artery stenosis</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="2092"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Ischaemic cardiomyopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Left ventricular failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="19" subjects_affected="19" subjects_at_risk="2092"/>
                <counts group_id="E2" events="19" subjects_affected="17" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Myocardial ischaemia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="2092"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Myocardial reperfusion injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Pericardial effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Right ventricular failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Silent myocardial infarction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Sinus node dysfunction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Ventricular arrhythmia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Ventricular extrasystoles</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Ventricular fibrillation</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Ventricular tachyarrhythmia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Ventricular tachycardia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Trifascicular block</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Congenital claw toe</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Encephalocele</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </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="2092"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Deafness unilateral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Vertigo positional</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Vestibular disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Goitre</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Keratitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Retinal detachment</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Retinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Retinal tear</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Vitreous haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal hernia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Acquired oesophageal web</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Anal spasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Chronic gastritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Crohn's disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Diabetic gastroenteropathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Diabetic gastroparesis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Diverticular perforation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Diverticulum</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Duodenal ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Enterovesical fistula</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Food poisoning</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Gastric polyps</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Gastric ulcer</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Gastric ulcer haemorrhage</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Gastric varices haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Gastritis erosive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Gastroduodenitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Gastrointestinal ulcer haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Ileus paralytic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Impaired gastric emptying</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Incarcerated umbilical hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="2092"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Large intestine polyp</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Lower gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Noninfective gingivitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Oesophagitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Pancreatic cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Pancreatitis chronic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Peptic ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Retroperitoneal haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Strangulated umbilical hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac death</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="8" subjects_affected="6" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Complication associated with device</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Multiple organ dysfunction syndrome</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="2092"/>
                <counts group_id="E2" events="10" subjects_affected="8" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Sudden cardiac death</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Sudden death</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="2092"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Vascular stent restenosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Catheter site haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Vascular stent thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </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="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Cholangitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="2092"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2092"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Cholecystitis chronic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="2092"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Hepatic cirrhosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Hepatorenal syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Hydrocholecystis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Jaundice</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Drug hypersensitivity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abdominal abscess</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Abscess intestinal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Abscess limb</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Atypical pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Bacterial sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="2092"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Bronchitis viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Bronchopulmonary aspergillosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Bronchopulmonary aspergillosis allergic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="2092"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Chronic hepatitis C</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Diabetic foot infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Diabetic gangrene</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Endocarditis bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Endophthalmitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Enterococcal sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Epididymitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Escherichia urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Febrile infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Fungal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Gangrene</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="2092"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Gas gangrene</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="2092"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>HIV infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Infectious pleural effusion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Infective exacerbation of bronchiectasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </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="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Kidney infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Klebsiella sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Mediastinitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Neuroborreliosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Nosocomial infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Paronychia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Parotitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Pelvic sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Perirectal abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Pneumocystis jirovecii pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="37" subjects_affected="35" subjects_at_risk="2092"/>
                <counts group_id="E2" events="31" subjects_affected="31" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Pneumonia respiratory syncytial viral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Pneumonia streptococcal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Pneumonia viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Postoperative abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Pulmonary tuberculosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Pyelonephritis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="2092"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Subdural empyema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Tuberculosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2092"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Urinary tract infection bacterial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Vulval abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Acetabulum fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Alcohol poisoning</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Ankle fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Avulsion fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Cardiac procedure complication</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Cervical vertebral fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Chemical peritonitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Concussion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Coronary artery restenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Craniocerebral injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Cystitis radiation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Face injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Femoral neck fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Fibula fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Flail chest</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Foot fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Forearm fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Gastrointestinal anastomotic leak</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Head injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Incarcerated incisional hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Incisional hernia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Jaw fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Joint dislocation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Lower limb fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Meniscus injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Multiple injuries</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Post procedural complication</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Post procedural haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Postoperative ileus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Procedural haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Radius fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Soft tissue injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Spinal cord injury cervical</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Stomal hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Synovial rupture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Thermal burn</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Tibia fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Toxicity to various agents</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Traumatic haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Upper limb fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Vascular graft occlusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Vascular pseudoaneurysm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Wrist fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Procedural pneumothorax</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Traumatic intracranial haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Blood glucose increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Blood sodium decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Heart rate increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Troponin increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus inadequate control</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Diabetic ketoacidosis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Diabetic metabolic decompensation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Fluid overload</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="2092"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="2092"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Obesity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Amyotrophy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Bursitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Foot deformity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Gouty arthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Intervertebral disc disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Lumbar spinal stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Osteitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="15" subjects_affected="14" subjects_at_risk="2092"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Periarthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Rotator cuff syndrome</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Spinal column stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Spinal osteoarthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Spinal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Spondylolisthesis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Trigger finger</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Adenocarcinoma gastric</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Adenocarcinoma of colon</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="2092"/>
                <counts group_id="E2" events="15" subjects_affected="10" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Benign neoplasm of eyelid</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Benign renal neoplasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Bladder cancer</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Bladder cancer recurrent</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Bladder neoplasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Bladder transitional cell carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Bone cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Brain neoplasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Breast cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Breast cancer in situ</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Breast cancer metastatic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Bronchial carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Cholangiocarcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Colon adenoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Colon cancer</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Colorectal cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Gastric cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Hepatic cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Hepatic neoplasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Hodgkin's disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Intraductal proliferative breast lesion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Lung adenocarcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Lung cancer metastatic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Lung carcinoma cell type unspecified stage IV</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Lung neoplasm malignant</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Lung squamous cell carcinoma stage II</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Malignant melanoma</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Meningioma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Metastases to liver</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Metastatic gastric cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Neoplasm malignant</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Neuroendocrine carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Non-Hodgkin's lymphoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Oesophageal carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Pancreatic carcinoma</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Pancreatic carcinoma metastatic</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Pancreatic neoplasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Parathyroid tumour benign</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Plasma cell myeloma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="2092"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Prostate cancer stage 0</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Prostate cancer stage II</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Prostatic adenoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Rectal cancer</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Renal cancer</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2092"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Renal cell carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Small cell lung cancer</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Small cell lung cancer metastatic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="9" subjects_affected="5" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of skin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Tonsil cancer metastatic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Transitional cell carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Urinary tract neoplasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Vocal cord neoplasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Benign ear neoplasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Bowen's disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Ear neoplasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Altered state of consciousness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Ataxia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Basal ganglia infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Basal ganglia stroke</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Brain stem infarction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Carotid artery stenosis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2092"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Cauda equina syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Cerebral haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2092"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Cerebral ischaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Cerebral small vessel ischaemic disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="2092"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Cerebrovascular insufficiency</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Cervical radiculopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Cervicobrachial syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Coma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Dementia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Dementia Alzheimer's type</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Diabetic neuropathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Embolic stroke</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Epilepsy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Facial paralysis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Haemorrhagic stroke</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Hypertensive encephalopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>IIIrd nerve paralysis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Intracranial aneurysm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="2092"/>
                <counts group_id="E2" events="17" subjects_affected="17" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Lacunar infarction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Loss of consciousness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Lumbar radiculopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Meralgia paraesthetica</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Monoparesis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Myelitis transverse</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Nerve root compression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Parkinson's disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Radiculopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="2092"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Thalamic infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Toxic encephalopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="2092"/>
                <counts group_id="E2" events="11" subjects_affected="11" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>VIth nerve paralysis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Vascular dementia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Vertebrobasilar insufficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Cerebellar infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device breakage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Device malfunction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Abnormal behaviour</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Acute stress disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Alcoholism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Major depression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Mental disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Panic attack</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Schizophrenia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Somatic symptom disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Stress</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Substance-induced mood disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Suicide attempt</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </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="11" subjects_affected="11" subjects_at_risk="2092"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Calculus urethral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Calculus urinary</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Chronic kidney disease</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Haemorrhage urinary tract</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="2092"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Renal colic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Stag horn calculus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Ureteric stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Ureterolithiasis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Urethral stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Urinary incontinence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </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="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Breast fibrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Genital prolapse</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Ovarian cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Prostatic dysplasia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Prostatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Uterine haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Uterine prolapse</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute pulmonary oedema</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="9" subjects_affected="7" subjects_at_risk="2092"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Pleurisy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Pulmonary mass</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Pulmonary oedema</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2092"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Sleep apnoea syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Decubitus ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Dermatosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Diabetic foot</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Skin lesion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Skin ulcer</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic aneurysm</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Aortic stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Arterial occlusive disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Circulatory collapse</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Dry gangrene</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Extremity necrosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="2092"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Hypertensive crisis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2092"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Hypertensive emergency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Iliac artery occlusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Intermittent claudication</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Peripheral arterial occlusive disease</sub_title>
                <counts group_id="E1" events="17" subjects_affected="14" subjects_at_risk="2092"/>
                <counts group_id="E2" events="11" subjects_affected="10" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Peripheral artery occlusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Peripheral artery stenosis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2092"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Peripheral artery thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Peripheral ischaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="2092"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Peripheral vascular disorder</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2092"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2100"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 19.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="788" subjects_at_risk="2092"/>
                <counts group_id="E2" subjects_affected="794" subjects_at_risk="2100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="167" subjects_affected="123" subjects_at_risk="2092"/>
                <counts group_id="E2" events="195" subjects_affected="145" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="163" subjects_affected="123" subjects_at_risk="2092"/>
                <counts group_id="E2" events="150" subjects_affected="120" subjects_at_risk="2100"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="131" subjects_affected="108" subjects_at_risk="2092"/>
                <counts group_id="E2" events="141" subjects_affected="98" subjects_at_risk="2100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood glucose increased</sub_title>
                <counts group_id="E1" events="139" subjects_affected="97" subjects_at_risk="2092"/>
                <counts group_id="E2" events="199" subjects_affected="139" subjects_at_risk="2100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="3990" subjects_affected="530" subjects_at_risk="2092"/>
                <counts group_id="E2" events="3688" subjects_affected="473" subjects_at_risk="2100"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Senior Vice President, Global Clinical Development</name_or_title>
      <organization>Merck Sharp &amp; Dohme Corp.</organization>
      <phone>1-800-672-6372</phone>
      <email>ClinicalTrialDisclosure@merck.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/NCT01703208
org study id: 3102-018
secondary id: 2012-002414-39
secondary id: MK-3102-018
nct id: NCT01703208
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate the cardiovascular (CV) safety profile of
      omarigliptin in participants with type 2 diabetes mellitus (T2DM). The primary hypothesis is
      that treatment with omarigliptin 25 mg once weekly is non-inferior to treatment with placebo
      and active comparators across the omarigliptin program with regard to the risk of developing
      a confirmed event in the primary CV composite endpoint.
The trial was amended to extend the length of the trial in order to meet FDA requirements for
      the post-approval assessment of cardiovascular (CV) safety. The trial now contains 2 time
      intervals: Period 1 and Period 2. Period 1 refers to the time interval up to this recent
      protocol amendment and Period 2, the time interval from this protocol amendment until the end
      of the study. Participants in Period 1 will be re-consented and continue into Period 2. If
      required, additional participants will be enrolled in Period 2. Stage 1 refers to the
      prefiling United States Food and Drug Administration (US FDA) requirement to rule out a 80%
      increased CV risk. Stage 2 refers to the US FDA post-marketing requirement to rule out a 30%
      increased CV risk. The Stage 1 assessment of CV risk occurred during Period 1 and was based
      on a meta-analysis of major adverse CV events (MACE) and unstable angina across the
      omarigliptin Phase 2/Phase 3 program. The Stage 2 assessment will be based on MACE in P018
      alone including CV events from both Period 1 and Period 2.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Number of Participants With MACE-plus (Confirmed Cardiovascular [CV]-Related Death, Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, or Hospitalization Due to Unstable Angina)
time frame: Up to 156 weeks
description: Participants with confirmed MACE-plus events (confirmed cardiovascular, CV-related death, nonfatal myocardial infarction [MI], nonfatal stroke, or hospitalization due to unstable angina). In the MK-3102-018 study, MACE plus events had a data cut-off date of April 15, 2015.
measure: Number of Participants With an Event of MACE (Confirmed CV-Related Death, Fatal and Nonfatal MI, and Fatal and Nonfatal Stroke)
time frame: Up to 179 weeks
description: Participants with an Event of MACE (confirmed cardiovascular, CV-related death, fatal and nonfatal myocardial infarction [MI], and fatal and nonfatal stroke).
measure: Number of Participants With an Event Per 100 Person-Years for First Event of MACE (Confirmed CV-Related Death, Fatal and Nonfatal MI, and Fatal and Nonfatal Stroke)
time frame: Up to 179 weeks
description: Participants with an event of MACE (confirmed cardiovascular, CV-related death, fatal and nonfatal myocardial infarction [MI], and fatal and nonfatal stroke). Person-years were calculated as the sum of all participants' follow-up time to first event.
measure: Change From Baseline in Hemoglobin A1C (A1C) at Week 18
time frame: Baseline and Week 18
description: A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 18 A1C minus the Week 0 A1C.
measure: Change From Baseline in A1C at Week 18 in a Sub-Study of Participants Taking Insulin (With or Without Metformin)
time frame: Baseline and Week 18
description: A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 18 A1C minus the Week 0 A1C.
measure: Percentage of Participants Who Experienced at Least One Adverse Event in a Sub-study of Participants Taking Insulin Excluding Data After Background Antihyperglycemic Agent (AHA) Change
time frame: Up to Week 18
description: An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
measure: Percentage of Participants Who Discontinued From Study Drug Due to an Adverse Event in a Sub-Study of Participants Taking Insulin Excluding Data After Background AHA Change
time frame: Up to Week 18
description: An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
measure: Number of Participants With an Event of CV-Related Death
time frame: Up to 179 weeks
description: Participants with adjudicated and confirmed AEs of cardiovascular-related death.
measure: Number of Participants With an Event Per 100 Person-Years of CV-Related Death
time frame: Up to 179 weeks
description: Participants with adjudicated and confirmed AEs of cardiovascular-related death. Person-years were calculated as the sum of all participants' follow-up time to event.
measure: Number of Participants With an Event of First MI (Fatal and Non-fatal)
time frame: Up to 179 weeks
description: Participants with adjudicated and confirmed AEs of fatal and non-fatal MI.
measure: Number of Participants With an Event Per 100 Person-Years of First MI (Fatal and Non-fatal)
time frame: Up to 179 weeks
description: Participants with adjudicated and confirmed AEs of fatal and non-fatal MI. Person-years were calculated as the sum of all participants' follow-up time to first event.
measure: Number of Participants With an Event of Stroke (Fatal and Non-fatal)
time frame: Up to 179 weeks
description: Participants with adjudicated and confirmed AEs fatal and non-fatal stroke.
measure: Number of Participants With an Event Per 100 Person-Years of First Stroke (Fatal and Non-fatal)
time frame: Up to 179 weeks
description: Participants with adjudicated and confirmed AEs fatal and non-fatal stroke. Person-years were calculated as the sum of all participants' follow-up time to event.
measure: Number of Participants With an Event of All-Cause Death
time frame: Up to 179 weeks
description: All-cause death was death from any cause.
measure: Number of Participants With an Event Per 100 Person-Years of the Event of All-Cause Death
time frame: Up to 179 weeks
description: All-cause death was death for any cause. Person-years were calculated as the sum of all participants' follow-up time to event.
measure: Change From Baseline in A1C at Week 142
time frame: Baseline and Week 142
description: A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 142 A1C minus the Week 0 A1C.
measure: Percentage of Participants Achieving a Target A1C <7.0 % (53 mmol/Mol) at 4 Months
time frame: 4 months
description: A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%).
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at 4 Months
time frame: Baseline and 4 months
description: This change from baseline reflects the Month 4 FPG minus the Week 0 FPG.
measure: Time to Initiation of Long-Term Insulin Therapy in Participants Not Receiving Insulin at Baseline
time frame: Up to 179 weeks
description: Long-term insulin therapy was defined as a continuous period of insulin use of more than 3 months.
measure: Percentage of Participants Who Experienced at Least One Adverse Event
time frame: Up to 234 weeks
description: An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
measure: Percentage of Participants Who Discontinued From Study Drug Due to an Adverse Event
time frame: Up to 212 weeks
description: An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
measure: Change From Baseline in FPG at Week 18 in a Sub-Study of Participants Taking Insulin
time frame: Baseline and Week 18
description: This change from baseline reflects the Week 18 FPG minus the Week 0 FPG.
measure: Percentage of Participants Achieving a Target A1C <7.0 % (53 mmol/Mol) at Week 18 in a Sub-Study of Participants Taking Insulin
time frame: 18 weeks
description: A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Analysis was performed with multiple data imputation.
measure: Number of Participants With an Event of First Hospitalization for Heart Failure (Exploratory)
time frame: Up to 179 weeks
description: Participants with adjudicated and confirmed events of first hospitalization for heart failure.
measure: Number of Participants With an Event Per 100 Person-years of the Event of the First Hospitalization for Heart Failure (Exploratory)
time frame: Up to 179 weeks
description: Participants with adjudicated and confirmed events of first hospitalization for heart failure. Person-years were calculated as the sum of all participants' follow-up time to event.
arm group label: Omarigliptin
arm group type: Experimental
description: Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
arm group label: Placebo
arm group type: Placebo Comparator
description: Matching placebo to omarigliptin capsule or tablet administered orally once weekly
intervention type: Drug
intervention name: Omarigliptin
description: Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
arm group label: Omarigliptin
intervention type: Drug
intervention name: Placebo
description: Matching placebo to omarigliptin capsule or tablet administered orally once weekly
arm group label: Placebo
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Merck Sharp & Dohme LLC
country: Argentina
country: Australia
country: Austria
country: Belgium
country: Brazil
country: Bulgaria
country: Canada
country: Chile
country: Colombia
country: Croatia
country: Czech Republic
country: Denmark
country: Finland
country: France
country: Georgia
country: Germany
country: Hong Kong
country: Hungary
country: Israel
country: Italy
country: Korea, Republic of
country: Lebanon
country: Lithuania
country: Malaysia
country: Mexico
country: Netherlands
country: New Zealand
country: Philippines
country: Poland
country: Romania
country: Russian Federation
country: Serbia
country: Slovakia
country: South Africa
country: Spain
country: Sweden
country: Taiwan
country: Ukraine
country: United Kingdom
country: United States
citation: Gantz I, Chen M, Suryawanshi S, Ntabadde C, Shah S, O'Neill EA, Engel SS, Kaufman KD, Lai E. A randomized, placebo-controlled study of the cardiovascular safety of the once-weekly DPP-4 inhibitor omarigliptin in patients with type 2 diabetes mellitus. Cardiovasc Diabetol. 2017 Sep 11;16(1):112. doi: 10.1186/s12933-017-0593-8.
PMID: 28893244
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: Yes
ipd description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
ipd url: http://engagezone.msd.com/ds_documentation.php
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 