<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/NCT01728116</url>
  </required_header>
  <id_info>
    <org_study_id>09-1</org_study_id>
    <nct_id>NCT01728116</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of EndoBarrier in Subjects With Type 2 Diabetes Who Are Obese</brief_title>
  <acronym>ENDO</acronym>
  <official_title>A Randomized, Multi-Center, Pivotal Efficacy and Safety Study Comparing the EndoBarrier Gastrointestinal Liner System vs. Sham for Glycemic Improvement in Inadequately Controlled Obese Type 2 Diabetic Subjects on Oral Anti-Diabetes Agents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GI Dynamics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GI Dynamics</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine if the EndoBarrier safely and effectively improves glycemic control in obese&#xD;
      subjects with type 2 diabetes&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, double blinded, prospective study. Subjects will be evaluated and&#xD;
      randomized to either the device or sham treatment group if they qualify for the study. A&#xD;
      comparison of glycemic control between the two groups will be assessed as the primary outcome&#xD;
      measurement as well as the safety profile of the device.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Higher than anticipated rate of Hepatic abscess (N=7)&#xD;
  </why_stopped>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">February 2016</primary_completion_date>
  <phase>N/A</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary Efficacy Endpoint: Improvement in HbA1c</measure>
    <time_frame>Baseline and12 months</time_frame>
    <description>Mean Change in HbA1c from Baseline to 12 Months in the mITT population with Bayesian Imputation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary Safety Endpoint: Early Device Removal Due to Device-Related SAE</measure>
    <time_frame>Baseline and 12 Months</time_frame>
    <description>Of the 161 subjects for whom data were available at 12 Months, 19 (11.8%) subjects experienced device-related SAEs that required an early device removal.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of Total Cholesterol Change at 12 Months Compared to Baseline</measure>
    <time_frame>Baseline and 12 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects Who Achieve HbA1c Less Than or Equal to 7.0% at 12 Months</measure>
    <time_frame>Baseline and 12 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LDL Change From Baseline</measure>
    <time_frame>Baseline and 12 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triglycerides Change From Baseline</measure>
    <time_frame>Baseline and 12 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting Glucose Change From Baseline</measure>
    <time_frame>Baseline and 12 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic BP Change From Baseline</measure>
    <time_frame>Baseline and 12 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diastolic BP Change From Baseline</measure>
    <time_frame>Baseline and 12 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects Who Achieve % Total Body Weight Loss Greater Than or Equal to 5% at 12 Months</measure>
    <time_frame>Baseline and 12 Months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">325</enrollment>
  <condition>Type 2 Diabetes</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Device (EndoBarrier)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Device for glycemic control</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Procedure</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>sham procedure</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>EndoBarrier</intervention_name>
    <description>Endoscopically-delivered and removable device comprised of an anchor that is placed in the duodenal bulb and a 60 cm long impermeable liner that passes distal from the anchor point</description>
    <arm_group_label>Device (EndoBarrier)</arm_group_label>
    <other_name>Duodenal-jejunal bypass liner (DJBL)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sham Procedure</intervention_name>
    <description>Endoscopic evaluation but no device placement</description>
    <arm_group_label>Sham Procedure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males/females aged ≥ 21 years and ≤ 65 years&#xD;
&#xD;
          -  Diagnosis of Type 2 Diabetes for ≤ 20 years&#xD;
&#xD;
          -  Obese individuals (BMI ≥ 30 kg/m2 and ≤ 55 kg/m2)&#xD;
&#xD;
          -  Stable doses (at least 3 months) of up to two anti-T2DM medications (MET, SU, DPP-4i&#xD;
             or TZD)&#xD;
&#xD;
          -  Glycemic state: HbA1c at screening ≥ 7.5% and ≤ 10.0%.&#xD;
&#xD;
          -  Subjects willing to comply with study requirements&#xD;
&#xD;
          -  Subjects who have signed an informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of type 1 diabetes mellitus or having any history of ketoacidosis&#xD;
&#xD;
          -  C-peptide &lt; 1.0 ng/mL&#xD;
&#xD;
          -  Triglyceride level &gt; 400 mg/dL&#xD;
&#xD;
          -  Vitamin D deficiency (&lt;20 ng/mL)&#xD;
&#xD;
          -  Male subjects with serum Creatinine &gt;1.5 mg/dl or female subjects with Creatinine &gt;1.4&#xD;
             mg/dL&#xD;
&#xD;
          -  Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet&#xD;
             count less than 100,000/microliter, or known coagulopathy&#xD;
&#xD;
          -  Height &lt; 5 feet (152.4 cm)&#xD;
&#xD;
          -  Current alcohol or drug addiction&#xD;
&#xD;
          -  Symptomatic kidney stones or gallstones within 6 months prior to randomization&#xD;
&#xD;
          -  Chronic pancreatitis or acute pancreatitis within 12 months of randomization&#xD;
&#xD;
          -  Diagnosis of osteoporosis or currently taking bisphosphonates or teriparatide&#xD;
&#xD;
          -  Diagnosis of an autoimmune connective tissue disorder (e.g., lupus erythematosus,&#xD;
             scleroderma)&#xD;
&#xD;
          -  Active gastroesophageal reflux disease [GERD] uncontrolled with a Proton Pump&#xD;
             Inhibitor (PPI)&#xD;
&#xD;
          -  Thyroid disease unless controlled with medication&#xD;
&#xD;
          -  Currently taking Non-Steroidal Anti-Inflammatory Drugs [NSAIDs] (e.g., aspirin,&#xD;
             ibuprofen, etc.) within 10 days prior to randomization and/or there is a need or&#xD;
             expected use of these agents during the trial 12 months post index procedure&#xD;
&#xD;
          -  Currently taking prescription antithrombotic therapy (e.g., anticoagulant or&#xD;
             antiplatelet agent) within 10 days prior to randomization and/or there is a need or&#xD;
             expected need to use during the trial 12 months post index procedure&#xD;
&#xD;
          -  Currently taking systemic corticosteroids, drugs known to affect GI motility,&#xD;
             prescription/over-the-counter weight loss medications, or medications known to cause&#xD;
             significant weight gain or weight loss within 30 days prior to randomization and/or&#xD;
             there is a need or expected need to use these medications during the trial 12 months&#xD;
             post index procedure&#xD;
&#xD;
          -  Medication for type 2 diabetes other than MET, SU, DPP-4i, and TZD (e.g., GLP1 or&#xD;
             insulin) within 3 months of screening&#xD;
&#xD;
          -  Chronic use of narcotics, opiates, benzodiazepines, or other addictive tranquilizers&#xD;
&#xD;
          -  Allergy or hypersensitivity to ceftriaxone, cephalosporins, penicillin, or any&#xD;
             equivalent antibiotics&#xD;
&#xD;
          -  Active Helicobacter pylori infection (Note: Subjects may be eligible after undergoing&#xD;
             2 weeks of antibiotic treatment without re-screening)&#xD;
&#xD;
          -  Previous GI surgery or abnormal GI anatomical finding that could preclude the ability&#xD;
             to place the EndoBarrier device, liner or affect the function of the liner&#xD;
&#xD;
          -  Abnormal pathologies or conditions of the gastrointestinal tract, including current&#xD;
             ulcers or Crohn's disease, history of atresias or untreated stenoses, current upper&#xD;
             gastrointestinal bleeding conditions within 3 months of randomization&#xD;
&#xD;
          -  Any condition or major illness that places the subject at undue risk by participating&#xD;
             in the study&#xD;
&#xD;
          -  Poor dentition not allowing complete chewing of food&#xD;
&#xD;
          -  Enrolled in another investigational study within 3 months of screening for this study&#xD;
             (Enrollment in observational studies is permitted)&#xD;
&#xD;
          -  Residing in a location without ready access to study site medical resources&#xD;
&#xD;
          -  Documented weight loss of &gt;10 pounds anytime during the 3 months preceding&#xD;
             randomization&#xD;
&#xD;
          -  Positive stool guaiac at time of screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lee M Kaplan, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Keith Gersin, MD</last_name>
    <role>Study Director</role>
    <affiliation>Carolinas Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic Arizona</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85259</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Little Rock Diagnostic Center (LRDC)</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cedars-Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford University School of Medicine</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado/ Anschutz Health &amp; Wellness Center</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kentucky Research Group</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tulane University Health Sciences Center</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112-2699</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MedStar Health Research Institute</name>
      <address>
        <city>Hyattsville</city>
        <state>Maryland</state>
        <zip>20782</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic Minnesota</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University</name>
      <address>
        <city>St Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Billings Clinic</name>
      <address>
        <city>Billings</city>
        <state>Montana</state>
        <zip>59101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beth Israel Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of North Carolina</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Legacy Research Institute</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endocrinology Consultants of East Tennessee &amp; Gastrointestinal Associates</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37909</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dallas Diabetes</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UT Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390-7170</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Methodist Hospital Research Institute</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.gidynamics.com/</url>
    <description>GI Dynamics website</description>
  </link>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 13, 2012</study_first_submitted>
  <study_first_submitted_qc>November 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 16, 2012</study_first_posted>
  <results_first_submitted>June 22, 2016</results_first_submitted>
  <results_first_submitted_qc>October 10, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 2, 2016</results_first_posted>
  <last_update_submitted>December 2, 2016</last_update_submitted>
  <last_update_submitted_qc>December 2, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>glycemic control, type 2 diabetes, device, obese</keyword>
  <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>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Up to 500 subjects were planned to be randomized into either the EndoBarrier or the sham control arm at a 2:1 ratio, respectively. Due to early termination of the trial, only 325 subjects were randomized with 216 EndoBarrier subjects and 109 sham control subjects.</recruitment_details>
      <pre_assignment_details>The mITT population for the primary analyses includes 213 EndoBarrier subjects and 107 sham control subjects. The remaining five (5) subjects (n=3 randomized to device; n=2 randomized to sham) were deemed ineligible before an attempted device placement due to findings identified during the upper endoscopy.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>EndoBarrier Group</title>
          <description>Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. Subjects also received a prophylactic dose of antibiotics on Procedure Day. Fluoroscopy was also used in conjunction with endoscopy to aid implantation of the EndoBarrier device. Medical Nutritional Therapy (MNT) counseling (as defined by the 2012 American Diabetes Association guidelines) was to be conducted at Baseline then Weeks 13, 26, 39, and 52 for both groups, and additionally at Week 65 for the EndoBarrier group.</description>
        </group>
        <group group_id="P2">
          <title>Sham Control Group</title>
          <description>Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.Medical Nutritional Therapy (MNT) counseling (as defined by the 2012 American Diabetes Association guidelines) was to be conducted at Baseline then Weeks 13, 26, 39, and 52.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="213">EndoBarrier mITT Subjects</participants>
                <participants group_id="P2" count="107">Sham mITT subjects</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="52">Completed to Week 78</participants>
                <participants group_id="P2" count="60">Completed to Week 52</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="161"/>
                <participants group_id="P2" count="47"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Sponsor Terminated Study</title>
              <participants_list>
                <participants group_id="P1" count="106"/>
                <participants group_id="P2" count="35"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Procedure/device failure</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Subject Non-Compliance</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Inter-current finding at procedure</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Incorrectly enrolled in Study</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>various not noted previously</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>mITT</population>
      <group_list>
        <group group_id="B1">
          <title>EndoBarrier Group</title>
          <description>Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. Subjects also received a prophylactic dose of antibiotics on Procedure Day. Fluoroscopy was also used in conjunction with endoscopy to aid implantation of the EndoBarrier device.</description>
        </group>
        <group group_id="B2">
          <title>Sham Control Group</title>
          <description>Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.</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="213"/>
            <count group_id="B2" value="107"/>
            <count group_id="B3" value="320"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>Age, range 25 to 65 years</description>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52.9" spread="8.19"/>
                    <measurement group_id="B2" value="51.8" spread="8.21"/>
                    <measurement group_id="B3" value="52.5" spread="8.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gender</title>
          <description>In both arms (Device and Sham) of the mITT population, 61.3% were female and 38.8% were male</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="127"/>
                    <measurement group_id="B2" value="69"/>
                    <measurement group_id="B3" value="196"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="86"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="124"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="194"/>
                    <measurement group_id="B2" value="93"/>
                    <measurement group_id="B3" value="287"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <description>Subjects were allowed to select more than one race.</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>American Indian or Alaska Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native Hawaiian or Other Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="165"/>
                    <measurement group_id="B2" value="80"/>
                    <measurement group_id="B3" value="245"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>More than one race</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown or Not Reported</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Weight (lbs)</title>
          <units>lbs</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="245.0" spread="47.46"/>
                    <measurement group_id="B2" value="245.6" spread="44.20"/>
                    <measurement group_id="B3" value="245.2" spread="46.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline BMI</title>
          <units>kg/m2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38.4" spread="5.74"/>
                    <measurement group_id="B2" value="38.3" spread="5.33"/>
                    <measurement group_id="B3" value="38.4" spread="5.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HbA1c (%) fasting bloodwork</title>
          <units>percent</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.8" spread="0.92"/>
                    <measurement group_id="B2" value="8.9" spread="0.89"/>
                    <measurement group_id="B3" value="8.8" spread="0.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Primary Efficacy Endpoint: Improvement in HbA1c</title>
        <description>Mean Change in HbA1c from Baseline to 12 Months in the mITT population with Bayesian Imputation</description>
        <time_frame>Baseline and12 months</time_frame>
        <population>All randomized subjects who at their baseline endoscopy are judged to be potential recipients of the device (meaning no abnormal pathologies and/or conditions are present). Any subject who has a device enter their body, regardless of eligibility or randomization assignment, is also included in the treatment arm of the mITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>EndoBarrier Group</title>
            <description>Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. Subjects also received a prophylactic dose of antibiotics on Procedure Day. Fluoroscopy was also used in conjunction with endoscopy to aid implantation of the EndoBarrier device.</description>
          </group>
          <group group_id="O2">
            <title>Sham Control Group</title>
            <description>Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.</description>
          </group>
        </group_list>
        <measure>
          <title>Primary Efficacy Endpoint: Improvement in HbA1c</title>
          <description>Mean Change in HbA1c from Baseline to 12 Months in the mITT population with Bayesian Imputation</description>
          <population>All randomized subjects who at their baseline endoscopy are judged to be potential recipients of the device (meaning no abnormal pathologies and/or conditions are present). Any subject who has a device enter their body, regardless of eligibility or randomization assignment, is also included in the treatment arm of the mITT population.</population>
          <units>Percentage of HbA1c</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="213"/>
                <count group_id="O2" value="107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.07" spread="1.5"/>
                    <measurement group_id="O2" value="-0.31" spread="1.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Primary Safety Endpoint: Early Device Removal Due to Device-Related SAE</title>
        <description>Of the 161 subjects for whom data were available at 12 Months, 19 (11.8%) subjects experienced device-related SAEs that required an early device removal.</description>
        <time_frame>Baseline and 12 Months</time_frame>
        <population>mITT without Imputation</population>
        <group_list>
          <group group_id="O1">
            <title>EndoBarrier Group</title>
            <description>Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. Subjects also received a prophylactic dose of antibiotics on Procedure Day. Fluoroscopy was also used in conjunction with endoscopy to aid implantation of the EndoBarrier device.</description>
          </group>
        </group_list>
        <measure>
          <title>Primary Safety Endpoint: Early Device Removal Due to Device-Related SAE</title>
          <description>Of the 161 subjects for whom data were available at 12 Months, 19 (11.8%) subjects experienced device-related SAEs that required an early device removal.</description>
          <population>mITT without Imputation</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="161"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.8" lower_limit="7.8" upper_limit="17.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Assessment of Total Cholesterol Change at 12 Months Compared to Baseline</title>
        <time_frame>Baseline and 12 Months</time_frame>
        <population>mITT population without imputation</population>
        <group_list>
          <group group_id="O1">
            <title>EndoBarrier Group</title>
            <description>Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. MITT population without imputation</description>
          </group>
          <group group_id="O2">
            <title>Sham Control Group</title>
            <description>Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.</description>
          </group>
        </group_list>
        <measure>
          <title>Assessment of Total Cholesterol Change at 12 Months Compared to Baseline</title>
          <population>mITT population without imputation</population>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="135"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.30" spread="34.39"/>
                    <measurement group_id="O2" value="-4.16" spread="47.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects Who Achieve HbA1c Less Than or Equal to 7.0% at 12 Months</title>
        <time_frame>Baseline and 12 Months</time_frame>
        <population>mITT population without imputation</population>
        <group_list>
          <group group_id="O1">
            <title>EndoBarrier Group</title>
            <description>Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. MITT population without imputation</description>
          </group>
          <group group_id="O2">
            <title>Sham Control Group</title>
            <description>Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Who Achieve HbA1c Less Than or Equal to 7.0% at 12 Months</title>
          <population>mITT population without imputation</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="135"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.81"/>
                    <measurement group_id="O2" value="9.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>LDL Change From Baseline</title>
        <time_frame>Baseline and 12 Months</time_frame>
        <population>mITT without imputation</population>
        <group_list>
          <group group_id="O1">
            <title>EndoBarrier Group</title>
            <description>Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. MITT population without imputation</description>
          </group>
          <group group_id="O2">
            <title>Sham Control Group</title>
            <description>Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.</description>
          </group>
        </group_list>
        <measure>
          <title>LDL Change From Baseline</title>
          <population>mITT without imputation</population>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="133"/>
                <count group_id="O2" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.76" spread="31.42"/>
                    <measurement group_id="O2" value="-10.54" spread="40.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Triglycerides Change From Baseline</title>
        <time_frame>Baseline and 12 Months</time_frame>
        <population>mITT population without imputation</population>
        <group_list>
          <group group_id="O1">
            <title>EndoBarrier Group</title>
            <description>Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. MITT population without imputation</description>
          </group>
          <group group_id="O2">
            <title>Sham Control Group</title>
            <description>Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.</description>
          </group>
        </group_list>
        <measure>
          <title>Triglycerides Change From Baseline</title>
          <population>mITT population without imputation</population>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="135"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-41.50" spread="105.76"/>
                    <measurement group_id="O2" value="2.26" spread="96.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Fasting Glucose Change From Baseline</title>
        <time_frame>Baseline and 12 Months</time_frame>
        <population>mITT population without imputation</population>
        <group_list>
          <group group_id="O1">
            <title>EndoBarrier Group</title>
            <description>Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. MITT population without imputation</description>
          </group>
          <group group_id="O2">
            <title>Sham Control Group</title>
            <description>Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.</description>
          </group>
        </group_list>
        <measure>
          <title>Fasting Glucose Change From Baseline</title>
          <population>mITT population without imputation</population>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="135"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-38.90" spread="66.08"/>
                    <measurement group_id="O2" value="5.31" spread="73.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Systolic BP Change From Baseline</title>
        <time_frame>Baseline and 12 Months</time_frame>
        <population>mITT population without imputation</population>
        <group_list>
          <group group_id="O1">
            <title>EndoBarrier Group</title>
            <description>Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. MITT population without imputation</description>
          </group>
          <group group_id="O2">
            <title>Sham Control Group</title>
            <description>Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.</description>
          </group>
        </group_list>
        <measure>
          <title>Systolic BP Change From Baseline</title>
          <population>mITT population without imputation</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="134"/>
                <count group_id="O2" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.76" spread="17.07"/>
                    <measurement group_id="O2" value="1.22" spread="16.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Diastolic BP Change From Baseline</title>
        <time_frame>Baseline and 12 Months</time_frame>
        <population>mITT population without imputation</population>
        <group_list>
          <group group_id="O1">
            <title>EndoBarrier Group</title>
            <description>Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. MITT population without imputation</description>
          </group>
          <group group_id="O2">
            <title>Sham Control Group</title>
            <description>Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.</description>
          </group>
        </group_list>
        <measure>
          <title>Diastolic BP Change From Baseline</title>
          <population>mITT population without imputation</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="134"/>
                <count group_id="O2" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.02" spread="9.91"/>
                    <measurement group_id="O2" value="1.51" spread="11.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects Who Achieve % Total Body Weight Loss Greater Than or Equal to 5% at 12 Months</title>
        <time_frame>Baseline and 12 Months</time_frame>
        <population>mITT population without imputation</population>
        <group_list>
          <group group_id="O1">
            <title>EndoBarrier Group</title>
            <description>Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. MITT population without imputation</description>
          </group>
          <group group_id="O2">
            <title>Sham Control Group</title>
            <description>Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Who Achieve % Total Body Weight Loss Greater Than or Equal to 5% at 12 Months</title>
          <population>mITT population without imputation</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="135"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.74"/>
                    <measurement group_id="O2" value="20.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>18 months for device subjects, 12 months for sham subjects</time_frame>
      <desc>The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).</desc>
      <group_list>
        <group group_id="E1">
          <title>EndoBarrier Group</title>
          <description>Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. Subjects also received a prophylactic dose of antibiotics on Procedure Day. Fluoroscopy was also used in conjunction with endoscopy to aid implantation of the EndoBarrier device.</description>
        </group>
        <group group_id="E2">
          <title>Sham Control Group</title>
          <description>Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedRA</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="53" subjects_at_risk="212"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Atrioventricular block complete</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Esophageal rupture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Gastrointestinal hemorrhage</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Intestinal perforation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Adhesion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Chest Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Complication of device removal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Obstruction</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Pseudopolyp</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Emphysematous pyelonephritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Incision site cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Liver abscess</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Scrotal infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Staphylococcal bacteremia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Esophageal injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </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="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Hyperglycemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Thyroid cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Mental status changes</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal failure acute</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Cholecystectomy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedRA</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="206" subjects_at_risk="212"/>
                <counts group_id="E2" subjects_affected="96" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="212"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Splenomegaly</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrioventricular block complete</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Hypoacusis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Sudden hearing loss</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Chalazion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Corneal lesion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Eye haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Eye swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Keratitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Mydriasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Ocular hyperaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Retinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Visual impairment</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Vitreous detachment</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal adhesions</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" events="96" subjects_affected="75" subjects_at_risk="212"/>
                <counts group_id="E2" events="17" subjects_affected="14" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="55" subjects_affected="45" subjects_at_risk="212"/>
                <counts group_id="E2" events="13" subjects_affected="13" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Abdominal mass</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="223" subjects_affected="125" subjects_at_risk="212"/>
                <counts group_id="E2" events="29" subjects_affected="22" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="9" subjects_affected="7" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Abdominal rigidity</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Abdominal tenderness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Abnormal faeces</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="212"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Barrett's oesophagus</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Bezoar</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Breath odour</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Cheilitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="62" subjects_affected="57" subjects_at_risk="212"/>
                <counts group_id="E2" events="16" subjects_affected="14" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="74" subjects_affected="57" subjects_at_risk="212"/>
                <counts group_id="E2" events="49" subjects_affected="39" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Diverticulum</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Duodenal stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Duodenal ulcer</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Duodenitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Enteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Erosive oesophagitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Eructation</sub_title>
                <counts group_id="E1" events="17" subjects_affected="15" subjects_at_risk="212"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Faecal incontinence</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Faeces discoloured</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" events="33" subjects_affected="29" subjects_at_risk="212"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Frequent bowel movements</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="212"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Gastric polyps</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Gastric ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Gastritis erosive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Gastrointestinal inflammation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="18" subjects_affected="15" subjects_at_risk="212"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Gingival pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Glossodynia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="212"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Haemorrhoidal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="212"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Hiatus hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Impaired gastric emptying</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Infrequent bowel movements</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Irritable bowel syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Large intestine polyp</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Lip pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Lip swelling</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="164" subjects_affected="111" subjects_at_risk="212"/>
                <counts group_id="E2" events="27" subjects_affected="24" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Odynophagia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Oesophageal discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Oesophageal rupture</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Oesophageal ulcer</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Oesophagitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Oral pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Pancreatic mass</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Peptic ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Retching</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Tongue cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Tooth loss</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="212"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Umbilical hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="85" subjects_affected="68" subjects_at_risk="212"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Adverse drug reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Device dislocation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="28" subjects_affected="27" subjects_at_risk="212"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Feeling cold</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Feeling hot</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Feeling jittery</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Local swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Obstruction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Oedema mucosal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Pseudopolyp</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="13" subjects_affected="10" subjects_at_risk="212"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Temperature intolerance</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Thirst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Biliary colic</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Biliary dilatation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Biliary dyskinesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Gallbladder polyp</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Hepatic cyst</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Hepatic lesion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Hepatic steatosis</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Hepatomegaly</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Liver injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Food allergy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Multiple allergies</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="212"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Acute sinusitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="212"/>
                <counts group_id="E2" events="7" subjects_affected="5" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Carbuncle</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Enterococcal bacteraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Fungal infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Fungal skin infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Gastroenteritis norovirus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Gastrointestinal viral infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="212"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Gingival infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Helicobacter infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="212"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="20" subjects_affected="20" subjects_at_risk="212"/>
                <counts group_id="E2" events="16" subjects_affected="13" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="212"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Sialoadenitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="8" subjects_affected="6" subjects_at_risk="212"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Tinea cruris</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Tooth abscess</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Tooth infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Trichomoniasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="17" subjects_affected="16" subjects_at_risk="212"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="212"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Vaginitis bacterial</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Vulvovaginal candidiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Vulvovaginal mycotic infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="212"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Ankle fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Arthropod sting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Excoriation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Foot fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Joint injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Lip injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Mouth injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Muscle strain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Oesophageal injury</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Post-traumatic neck syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Post-traumatic pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Thermal burn</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Amylase decreased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Blood albumin abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="212"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Blood calcium decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Blood calcium increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Blood chloride decreased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Blood cholesterol decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Blood cholesterol increased</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="212"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Blood creatinine decreased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Blood electrolytes decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Blood glucose increased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="212"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Blood iron decreased</sub_title>
                <counts group_id="E1" events="27" subjects_affected="24" subjects_at_risk="212"/>
                <counts group_id="E2" events="10" subjects_affected="9" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Blood iron increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Blood magnesium decreased</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="212"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Blood potassium decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Blood potassium increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Blood sodium decreased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="212"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Blood triglycerides increased</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="212"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Blood urea increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Carbon dioxide decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Electrocardiogram abnormal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Glycosylated haemoglobin increased</sub_title>
                <counts group_id="E1" events="10" subjects_affected="8" subjects_at_risk="212"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Haematocrit decreased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="212"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Haematocrit increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Haemoglobin decreased</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Haemoglobin increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>High density lipoprotein decreased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Insulin C-peptide increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Iron binding capacity total increased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="212"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Laboratory test abnormal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Lipase decreased</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Lipids increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Liver function test abnormal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Low density lipoprotein decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Low density lipoprotein increased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Oxygen saturation decreased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>QRS axis abnormal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Serum ferritin decreased</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Serum ferritin increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Transferrin saturation decreased</sub_title>
                <counts group_id="E1" events="28" subjects_affected="21" subjects_at_risk="212"/>
                <counts group_id="E2" events="16" subjects_affected="13" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Transferrin saturation increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Vitamin B12 decreased</sub_title>
                <counts group_id="E1" events="13" subjects_affected="11" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Vitamin B12 increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Vitamin D decreased</sub_title>
                <counts group_id="E1" events="15" subjects_affected="14" subjects_at_risk="212"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Hyperuricaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Electrolyte imbalance</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Fluid overload</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" events="8" subjects_affected="3" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="72" subjects_affected="36" subjects_at_risk="212"/>
                <counts group_id="E2" events="33" subjects_affected="12" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Increased appetite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Iron deficiency</sub_title>
                <counts group_id="E1" events="45" subjects_affected="42" subjects_at_risk="212"/>
                <counts group_id="E2" events="14" subjects_affected="14" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Vitamin B12 deficiency</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Vitamin D deficiency</sub_title>
                <counts group_id="E1" events="14" subjects_affected="14" subjects_at_risk="212"/>
                <counts group_id="E2" events="13" subjects_affected="12" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="212"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="56" subjects_affected="45" subjects_at_risk="212"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Bone loss</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Bursitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Fasciitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Groin pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Joint stiffness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Joint swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Limb discomfort</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Monarthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="212"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Musculoskeletal discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Musculoskeletal stiffness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="212"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="11" subjects_affected="9" subjects_at_risk="212"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Pain in jaw</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Tendonitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Tenosynovitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Adenocarcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Benign neoplasm of thyroid gland</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Breast cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Renal cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Carpal tunnel syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Diabetic neuropathy</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Disturbance in attention</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="12" subjects_affected="11" subjects_at_risk="212"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Dizziness postural</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="25" subjects_affected="24" subjects_at_risk="212"/>
                <counts group_id="E2" events="23" subjects_affected="18" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Migraine with aura</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Poor quality sleep</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Sciatic nerve neuropathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Sinus headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>VIIth nerve paralysis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Pregnancy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Chromaturia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Micturition urgency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Polyuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Renal cyst</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Renal mass</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Amenorrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Benign prostatic hyperplasia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Breast cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Breast mass</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Fallopian tube disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Menopausal symptoms</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Prostatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Scrotal mass</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Uterine haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Vulvovaginal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="212"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Dysphonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Hiccups</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Increased upper airway secretion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="54" subjects_affected="40" subjects_at_risk="212"/>
                <counts group_id="E2" events="25" subjects_affected="22" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Pleuritic pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Pulmonary congestion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Respiratory distress</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Respiratory tract congestion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Sinus congestion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Throat irritation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Tonsillar inflammation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Blister</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Dermal cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Diabetic ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Excessive granulation tissue</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Ingrowing nail</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Night sweats</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Onychoclasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="212"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Rash erythematous</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Rosacea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Skin discolouration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Artificial crown procedure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Knee operation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Nephrectomy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Rhinoplasty</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Skin lesion excision</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Wisdom teeth removal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Peripheral coldness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Shock</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Varicose vein</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="108"/>
              </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>PI to provide to Sponsor for review at least sixty (60) days in advance of submission for publication. Sponsor reserves the right to delete any Confidential Information or other proprietary information of Sponsor (including trade secrets but not including Results) from the proposed publication or presentation.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The ENDO Trial was stopped early due to a higher than anticipated rate of hepatic abscess (n=7).</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Brian Callahan</name_or_title>
      <organization>GI Dynamics, Inc</organization>
      <phone>781.357.3302</phone>
      <email>bcallahan@gidynamics.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/NCT01728116
org study id: 09-1
nct id: NCT01728116
lead sponsor: 
has dmc: Yes
To determine if the EndoBarrier safely and effectively improves glycemic control in obese
      subjects with type 2 diabetes
This is a randomized, double blinded, prospective study. Subjects will be evaluated and
      randomized to either the device or sham treatment group if they qualify for the study. A
      comparison of glycemic control between the two groups will be assessed as the primary outcome
      measurement as well as the safety profile of the device.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Primary Efficacy Endpoint: Improvement in HbA1c
time frame: Baseline and12 months
description: Mean Change in HbA1c from Baseline to 12 Months in the mITT population with Bayesian Imputation
measure: Primary Safety Endpoint: Early Device Removal Due to Device-Related SAE
time frame: Baseline and 12 Months
description: Of the 161 subjects for whom data were available at 12 Months, 19 (11.8%) subjects experienced device-related SAEs that required an early device removal.
measure: Assessment of Total Cholesterol Change at 12 Months Compared to Baseline
time frame: Baseline and 12 Months
measure: Percentage of Subjects Who Achieve HbA1c Less Than or Equal to 7.0% at 12 Months
time frame: Baseline and 12 Months
measure: LDL Change From Baseline
time frame: Baseline and 12 Months
measure: Triglycerides Change From Baseline
time frame: Baseline and 12 Months
measure: Fasting Glucose Change From Baseline
time frame: Baseline and 12 Months
measure: Systolic BP Change From Baseline
time frame: Baseline and 12 Months
measure: Diastolic BP Change From Baseline
time frame: Baseline and 12 Months
measure: Percentage of Subjects Who Achieve % Total Body Weight Loss Greater Than or Equal to 5% at 12 Months
time frame: Baseline and 12 Months
arm group label: Device (EndoBarrier)
arm group type: Experimental
description: Device for glycemic control
arm group label: Sham Procedure
arm group type: Sham Comparator
description: sham procedure
intervention type: Device
intervention name: EndoBarrier
description: Endoscopically-delivered and removable device comprised of an anchor that is placed in the duodenal bulb and a 60 cm long impermeable liner that passes distal from the anchor point
arm group label: Device (EndoBarrier)
other name: Duodenal-jejunal bypass liner (DJBL)
intervention type: Procedure
intervention name: Sham Procedure
description: Endoscopic evaluation but no device placement
arm group label: Sham Procedure
criteria: 
gender: All
minimum age: 21 Years
maximum age: 65 Years
healthy volunteers: No
last name: Lee M Kaplan, MD, PhD
role: Study Chair
affiliation: Massachusetts General Hospital
last name: Keith Gersin, MD
role: Study Director
affiliation: Carolinas Medical Center
facility: 
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country: United States
url: http://www.gidynamics.com/
description: GI Dynamics website
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: Yes
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The ENDO Trial was stopped early due to a higher than anticipated rate of hepatic abscess (n=7).
point of contact: 