<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/NCT03235050</url>
  </required_header>
  <id_info>
    <org_study_id>D5670C00004</org_study_id>
    <nct_id>NCT03235050</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Efficacy and Safety of MEDI0382 in the Treatment of Overweight and Obese Subjects With Type 2 Diabetes</brief_title>
  <official_title>A Phase IIb, Randomised, Parallel, Double-Blind Placebo-Controlled and Open-Label Active Comparator Study to Evaluate the Efficacy and Safety of MEDI0382 in the Treatment of Overweight and Obese Subjects With Type 2 Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>MedImmune LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>AstraZeneca</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to evaluate the dose range for MEDI0382 with respect to blood glucose&#xD;
      control and weight loss effects, as well as to further explore the safety profile of MEDI0382&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2, 2017</start_date>
  <completion_date type="Actual">June 14, 2019</completion_date>
  <primary_completion_date type="Actual">May 3, 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Randomised, parallel, double-blind, placebo-controlled study with an open-label active comparator.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>The study will be conducted in a double-blind fashion for MEDI0382 and placebo. The sponsor staff, the subjects, and the Investigators involved in the treatment of subjects or in the clinical evaluation of subjects will not be aware of the treatment received. Liraglutide will be provided in an open-label active comparator arm.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in HbA1c</measure>
    <time_frame>From baseline to 14 weeks</time_frame>
    <description>To assess the effect of 100, 200, 300 μg of cotadutide on HbA1c versus placebo</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent Change in Body Weight</measure>
    <time_frame>From baseline to 14 weeks</time_frame>
    <description>To assess the effect of 100, 200, 300 μg of cotadutide on body weight versus placebo</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in HbA1c</measure>
    <time_frame>from baseline to 26 weeks and 54 weeks</time_frame>
    <description>To assess the effect of 100, 200, 300 μg of cotadutide on HbA1c versus placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving an HbA1c Target &lt; 7.0%</measure>
    <time_frame>after 14, 26, and 54 weeks</time_frame>
    <description>To assess the effect of 100, 200, and 300 μg of cotadutide on percentage of participants achieving an HbA1c target of &lt;7% versus placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change in Body Weight</measure>
    <time_frame>from baseline to 26 weeks and 54 weeks</time_frame>
    <description>To assess the effect of 100, 200, and 300 μg of cotadutide on body weight versus placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Change in Body Weight</measure>
    <time_frame>from baseline to 14 weeks, 26 weeks and 54 weeks</time_frame>
    <description>To assess the effect of 100, 200, 300 μg of cotadutide on body weight versus placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change in Body Weight Versus Active Comparator</measure>
    <time_frame>from baseline to 14 weeks, 26 weeks and 54 weeks</time_frame>
    <description>To assess the effect of 100, 200, and 300 μg of cotadutide on body weight versus liraglutide 1.8 mg once daily</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Change in Body Weight Versus Active Comparator</measure>
    <time_frame>from baseline to 14 weeks, 26 weeks and 54 weeks</time_frame>
    <description>To assess the effect of 100, 200, and 300 μg of cotadutide on body weight versus liraglutide 1.8 mg once daily</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Weight Loss of ≥5% and ≥10%</measure>
    <time_frame>after 14 weeks, 26 weeks and 54 weeks</time_frame>
    <description>To assess the effect of 100, 200, and 300 μg of cotadutide on percentage of subjects achieving weight loss of ≥5% and ≥10% versus placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Rescued or Discontinued for Lack of Glycaemic Control</measure>
    <time_frame>at 14 weeks, 26 weeks and 54 weeks</time_frame>
    <description>To assess the effect of 100, 200, and 300 μg of cotadutide on the requirement for additional blood glucose-lowering therapies versus placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic (PK) Endpoint: Trough Plasma Concentration (Cmin)</measure>
    <time_frame>Time points at which outcome measure were assessed for plasma concentration were Weeks 1,2,6,10,14,18,22,26, and 54</time_frame>
    <description>To characterise the PK profile of 100, 200, and 300 μg of cotadutide</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity Endpoint: Overall Antidrug Antibody (ADA) Incidence (Number and Percentage of Positive Partipants)</measure>
    <time_frame>Baseline through 54-week treatment period and 28-day follow-up</time_frame>
    <description>To characterise the immunogenicity of 100, 200, and 300 μg of cotadutide</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity Endpoint: Median Titer of the Anti-Drug Antibodies (ADA) to MEDI0382 in the Positive Participants</measure>
    <time_frame>Baseline through 54-week treatment period and 28-day follow-up</time_frame>
    <description>To characterise the immunogenicity of 100, 200, and 300 μg of cotadutide</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">834</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>MEDI0382 low dose + Metformin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug: MEDI0382 low dose Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MEDI0382 mid dose + Metformin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug: MEDI0382 mid dose Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MEDI0382 high dose + Metformin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug: MEDI0382 high dose Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo + Metformin</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Drug: Placebo Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Liraglutide + Metformin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Drug: Liraglutide Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MEDI0382 low dose</intervention_name>
    <description>Pharmaceutical form: solution Route of administration: subcutaneous</description>
    <arm_group_label>MEDI0382 low dose + Metformin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MEDI0382 mid dose</intervention_name>
    <description>Pharmaceutical form: solution Route of administration: subcutaneous</description>
    <arm_group_label>MEDI0382 mid dose + Metformin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MEDI0382 high dose</intervention_name>
    <description>Pharmaceutical form: solution Route of administration: subcutaneous</description>
    <arm_group_label>MEDI0382 high dose + Metformin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Pharmaceutical form: solution Route of administration: subcutaneous</description>
    <arm_group_label>Placebo + Metformin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Liraglutide</intervention_name>
    <description>Pharmaceutical form: solution Route of administration: subcutaneous</description>
    <arm_group_label>Liraglutide + Metformin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Provision of informed consent&#xD;
&#xD;
          -  Male and female subjects aged ≥ 18 years at screening&#xD;
&#xD;
          -  Body mass index ≥ 25 kg/m2 at screening&#xD;
&#xD;
          -  HbA1c range of 7.0% to 10.5% (inclusive) at screening&#xD;
&#xD;
          -  Diagnosed with type-2 diabetes mellitus (T2DM) and treated with metformin (stable dose&#xD;
             of ≥1500 mg/day or maximal tolerated dose) for at least 2 months prior to screening.&#xD;
             Use of another glucose-lowering medication for up to 2 weeks in the 2 months prior to&#xD;
             screening is acceptable&#xD;
&#xD;
          -  Women of childbearing potential (WOCBP), not breastfeeding and using appropriate birth&#xD;
             control to avoid pregnancy throughout the study and for up to 4 weeks after the last&#xD;
             dose of investigational product (IP), with a negative pregnancy test within 72 hours&#xD;
             prior to the start of IP&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of, or any existing condition that, in the opinion of the Investigator, would&#xD;
             interfere with evaluation of the IP, put the subject at risk, influence the subject's&#xD;
             ability to participate or affect the interpretation of the results of the study and/or&#xD;
             any subject unable or unwilling to follow study procedures&#xD;
&#xD;
          -  Any subject who has received another IP as part of a clinical study or a GLP-1&#xD;
             receptor agonist containing preparation within the last 30 days or 5 half lives of the&#xD;
             drug (whichever is longer) at the time of screening&#xD;
&#xD;
          -  Severe allergy/hypersensitivity to any of the proposed study treatments or excipients&#xD;
&#xD;
          -  Symptoms of acutely decompensated blood glucose control, a history of type 1 diabetes&#xD;
             mellitus or diabetic ketoacidosis, or if the subject has been treated with daily&#xD;
             subcutaneous (SC) insulin for a period longer than 2 weeks within 90 days prior to&#xD;
             screening&#xD;
&#xD;
          -  Acute or chronic pancreatitis. Subjects with serum triglyceride concentrations above&#xD;
             1000 mg/dL (11 mmol/L) at screening&#xD;
&#xD;
          -  Significant inflammatory bowel disease or other severe disease or surgery affecting&#xD;
             the upper Gastrointestinal (GI) tract&#xD;
&#xD;
          -  Significant hepatic disease&#xD;
&#xD;
          -  Impaired renal function defined as estimated glomerular filtration rate (eGFR) ≤30&#xD;
             mL/minute/1.73m2 at screening&#xD;
&#xD;
          -  Severely uncontrolled hypertension&#xD;
&#xD;
          -  Unstable angina pectoris, myocardial infarction (MI), transient ischaemic attack&#xD;
             (TIA), or stroke within 3 months prior to screening&#xD;
&#xD;
          -  Severe congestive heart failure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>130 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chandler</city>
        <state>Arizona</state>
        <zip>85224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Glendale</city>
        <state>Arizona</state>
        <zip>85306</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Glendale</city>
        <state>Arizona</state>
        <zip>85308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Mesa</city>
        <state>Arizona</state>
        <zip>85213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30067</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Evansville</city>
        <state>Indiana</state>
        <zip>47715</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70808</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Metairie</city>
        <state>Louisiana</state>
        <zip>70006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Elkridge</city>
        <state>Maryland</state>
        <zip>21075</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bridgeton</city>
        <state>Missouri</state>
        <zip>63044</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Morehead City</city>
        <state>North Carolina</state>
        <zip>28557</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Greer</city>
        <state>South Carolina</state>
        <zip>29651</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77040</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77074</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Layton</city>
        <state>Utah</state>
        <zip>84014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Arlington</city>
        <state>Virginia</state>
        <zip>22206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Manassas</city>
        <state>Virginia</state>
        <zip>20110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Botevgrad</city>
        <zip>2140</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kozloduy</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kyustendil</city>
        <zip>2500</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lukovit</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Petrich</city>
        <zip>2850</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Pleven</city>
        <zip>5800</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Plovdiv</city>
        <zip>4000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Russe</city>
        <zip>7002</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sofia</city>
        <zip>1223</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sofia</city>
        <zip>1407</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sofia</city>
        <zip>1606</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sofia</city>
        <zip>1618</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Stara Zagora</city>
        <zip>6000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Red Deer</city>
        <state>Alberta</state>
        <zip>T4N 6V7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sherwood Park</city>
        <state>Alberta</state>
        <zip>T8L 0N2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Burlington</city>
        <state>Ontario</state>
        <zip>L7M 4Y1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Etobicoke</city>
        <state>Ontario</state>
        <zip>M9W 4L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Guelph</city>
        <state>Ontario</state>
        <zip>N1H 1B1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N5W 6A2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6G 5A9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Newmarket</city>
        <state>Ontario</state>
        <zip>L3Y 5G8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sarnia</city>
        <state>Ontario</state>
        <zip>N7T 4X3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Thornhill</city>
        <state>Ontario</state>
        <zip>L4J 8L7</zip>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4G 3E8</zip>
        <country>Canada</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Levis</city>
        <state>Quebec</state>
        <zip>G6W 0M5</zip>
        <country>Canada</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
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        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4A 3T2</zip>
        <country>Canada</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4N 2W2</zip>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Saint-Marc-des-Carrieres</city>
        <state>Quebec</state>
        <zip>G0A 4B0</zip>
        <country>Canada</country>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Beroun</city>
        <zip>266 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Jilove u Prahy</city>
        <zip>254 01</zip>
        <country>Czechia</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Pardubice</city>
        <zip>530 02</zip>
        <country>Czechia</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Plzen - Severni Predmesti</city>
        <zip>301 00</zip>
        <country>Czechia</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Plzen</city>
        <zip>301 66</zip>
        <country>Czechia</country>
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    </facility>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Praha - Klanovice</city>
        <zip>190 14</zip>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Praha 10</city>
        <zip>104 00</zip>
        <country>Czechia</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Praha 4</city>
        <zip>140 00</zip>
        <country>Czechia</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Praha 4</city>
        <zip>149 00</zip>
        <country>Czechia</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Praha</city>
        <zip>140 59</zip>
        <country>Czechia</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Uherske Hradiste</city>
        <zip>686 01</zip>
        <country>Czechia</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Aschaffenburg</city>
        <zip>63739</zip>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Berlin</city>
        <zip>10437</zip>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Berlin</city>
        <zip>10787</zip>
        <country>Germany</country>
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    </facility>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Eschweiler</city>
        <zip>52249</zip>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Essen</city>
        <zip>45136</zip>
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    <facility>
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      <address>
        <city>Essen</city>
        <zip>45359</zip>
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    <facility>
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      <address>
        <city>Gelnhausen</city>
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      <address>
        <city>Hamburg</city>
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      <address>
        <city>Hof</city>
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    <facility>
      <name>Research Site</name>
      <address>
        <city>Löhne</city>
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    <facility>
      <name>Research Site</name>
      <address>
        <city>Lübeck</city>
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    <facility>
      <name>Research Site</name>
      <address>
        <city>Magdeburg</city>
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      <name>Research Site</name>
      <address>
        <city>Mannheim</city>
        <zip>68163</zip>
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    <facility>
      <name>Research Site</name>
      <address>
        <city>Munster</city>
        <zip>48145</zip>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Oldenburg</city>
        <zip>23758</zip>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Pirna</city>
        <zip>01796</zip>
        <country>Germany</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Rhaunen</city>
        <zip>55624</zip>
        <country>Germany</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Villingen-Schwenningen</city>
        <zip>78048</zip>
        <country>Germany</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Guadalajara</city>
        <zip>44670</zip>
        <country>Mexico</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Monterrey</city>
        <zip>66465</zip>
        <country>Mexico</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>México</city>
        <zip>03300</zip>
        <country>Mexico</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>México</city>
        <zip>11650</zip>
        <country>Mexico</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Veracruz</city>
        <zip>91900</zip>
        <country>Mexico</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Veracruz</city>
        <zip>91910</zip>
        <country>Mexico</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chelyabinsk</city>
        <zip>454091</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ekaterinburg</city>
        <zip>620039</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
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      <address>
        <city>Izhevsk</city>
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        <country>Russian Federation</country>
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  <location>
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      <address>
        <city>Kemerovo</city>
        <zip>650066</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Moscow</city>
        <zip>119034</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Moscow</city>
        <zip>119435</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Moscow</city>
        <zip>125367</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
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      <address>
        <city>Novosibirsk</city>
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        <country>Russian Federation</country>
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      <address>
        <city>Perm</city>
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      <address>
        <city>Perm</city>
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      <address>
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      <address>
        <city>Saint-Petersburg</city>
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      <address>
        <city>St. Petersburg</city>
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    <facility>
      <name>Research Site</name>
      <address>
        <city>St.Petersburg</city>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Vladikavkaz</city>
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      <address>
        <city>Volgograd</city>
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      <name>Research Site</name>
      <address>
        <city>Banska Bystrica</city>
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      <address>
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        <city>Dolny Kubin</city>
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    <facility>
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      <address>
        <city>Levice</city>
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    <facility>
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      <address>
        <city>Lucenec</city>
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      <address>
        <city>Namestovo</city>
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    <facility>
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        <city>Nove Mesto nad Vahom</city>
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        <city>Prievidza</city>
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      <address>
        <city>Rimavska Sobota</city>
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        <country>Slovakia</country>
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        <country>Slovakia</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Zilina</city>
        <zip>010 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>Czechia</country>
    <country>Germany</country>
    <country>Mexico</country>
    <country>Russian Federation</country>
    <country>Slovakia</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Hungary</country>
  </removed_countries>
  <link>
    <url>https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;amp;parentIdentifier=D5670C00004&amp;amp;attachmentIdentifier=d3772b2d-e5a9-4fef-b796-e371735f6b2d&amp;amp;fileName=D5670C00004_SAP_redacted.pdf&amp;amp;versionIdentifier=</url>
    <description>D5670C00004 SAP redacted</description>
  </link>
  <link>
    <url>https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;amp;parentIdentifier=D5670C00004&amp;amp;attachmentIdentifier=e91d84a4-416d-4262-aea8-98b99f6854c5&amp;amp;fileName=D5670C00004_CSP_redacted.pdf&amp;amp;versionIdentifier=</url>
    <description>D5670C00004 CSP redacted</description>
  </link>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 21, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <results_first_submitted>June 3, 2020</results_first_submitted>
  <results_first_submitted_qc>July 3, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">July 20, 2020</results_first_posted>
  <disposition_first_submitted>March 7, 2019</disposition_first_submitted>
  <disposition_first_submitted_qc>July 3, 2020</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">July 20, 2020</disposition_first_posted>
  <last_update_submitted>July 31, 2020</last_update_submitted>
  <last_update_submitted_qc>July 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liraglutide</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 4, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/50/NCT03235050/Prot_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 20, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/50/NCT03235050/SAP_003.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Placebo / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
        </group>
        <group group_id="P2">
          <title>Liraglutide</title>
          <description>Liraglutide + Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
        </group>
        <group group_id="P3">
          <title>MEDI0382 100 mcg</title>
          <description>MEDI0382(cotadutide) low dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
        </group>
        <group group_id="P4">
          <title>MEDI0382 200 mcg</title>
          <description>MEDI0382(cotadutide) mid dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
        </group>
        <group group_id="P5">
          <title>MEDI0382 300 mcg</title>
          <description>MEDI0382(cotadutide) high dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="112"/>
                <participants group_id="P2" count="110"/>
                <participants group_id="P3" count="100"/>
                <participants group_id="P4" count="256"/>
                <participants group_id="P5" count="256"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="108"/>
                <participants group_id="P2" count="105"/>
                <participants group_id="P3" count="96"/>
                <participants group_id="P4" count="242"/>
                <participants group_id="P5" count="245"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="14"/>
                <participants group_id="P5" count="11"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="5"/>
                <participants group_id="P5" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other reasons</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Placebo / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
        </group>
        <group group_id="B2">
          <title>Liraglutide</title>
          <description>Liraglutide + Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
        </group>
        <group group_id="B3">
          <title>MEDI0382 100 mcg</title>
          <description>MEDI0382 low dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
        </group>
        <group group_id="B4">
          <title>MEDI0382 200 mcg</title>
          <description>MEDI0382 mid dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
        </group>
        <group group_id="B5">
          <title>MEDI0382 300 mcg</title>
          <description>MEDI0382 high dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
        </group>
        <group group_id="B6">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="112"/>
            <count group_id="B2" value="110"/>
            <count group_id="B3" value="100"/>
            <count group_id="B4" value="256"/>
            <count group_id="B5" value="256"/>
            <count group_id="B6" value="834"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57.3" spread="9.5"/>
                    <measurement group_id="B2" value="55.5" spread="9.8"/>
                    <measurement group_id="B3" value="57.6" spread="9.9"/>
                    <measurement group_id="B4" value="57.3" spread="9.9"/>
                    <measurement group_id="B5" value="56.3" spread="10.2"/>
                    <measurement group_id="B6" value="56.8" spread="9.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="57"/>
                    <measurement group_id="B4" value="147"/>
                    <measurement group_id="B5" value="129"/>
                    <measurement group_id="B6" value="448"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="43"/>
                    <measurement group_id="B4" value="109"/>
                    <measurement group_id="B5" value="127"/>
                    <measurement group_id="B6" value="386"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="107"/>
                    <measurement group_id="B2" value="103"/>
                    <measurement group_id="B3" value="99"/>
                    <measurement group_id="B4" value="245"/>
                    <measurement group_id="B5" value="252"/>
                    <measurement group_id="B6" value="806"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in HbA1c</title>
        <description>To assess the effect of 100, 200, 300 μg of cotadutide on HbA1c versus placebo</description>
        <time_frame>From baseline to 14 weeks</time_frame>
        <population>ITT population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
          </group>
          <group group_id="O2">
            <title>MEDI0382 100 mcg</title>
            <description>MEDI0382 low dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
          </group>
          <group group_id="O3">
            <title>MEDI0382 200 mcg</title>
            <description>MEDI0382 mid dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
          </group>
          <group group_id="O4">
            <title>MEDI0382 300 mcg</title>
            <description>MEDI0382 high dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
          </group>
        </group_list>
        <measure>
          <title>Change in HbA1c</title>
          <description>To assess the effect of 100, 200, 300 μg of cotadutide on HbA1c versus placebo</description>
          <population>ITT population</population>
          <units>percentage</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="112"/>
                <count group_id="O2" value="100"/>
                <count group_id="O3" value="256"/>
                <count group_id="O4" value="256"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.18" lower_limit="-0.34" upper_limit="-0.02"/>
                    <measurement group_id="O2" value="-1.01" lower_limit="-1.18" upper_limit="-0.84"/>
                    <measurement group_id="O3" value="-1.22" lower_limit="-1.33" upper_limit="-1.11"/>
                    <measurement group_id="O4" value="-1.09" lower_limit="-1.20" upper_limit="-0.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.83</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.06</ci_lower_limit>
            <ci_upper_limit>-0.59</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-1.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.23</ci_lower_limit>
            <ci_upper_limit>-0.85</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.91</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.11</ci_lower_limit>
            <ci_upper_limit>-0.72</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percent Change in Body Weight</title>
        <description>To assess the effect of 100, 200, 300 μg of cotadutide on body weight versus placebo</description>
        <time_frame>From baseline to 14 weeks</time_frame>
        <population>ITT population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
          </group>
          <group group_id="O2">
            <title>MEDI0382 100 mcg</title>
            <description>MEDI0382 low dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
          </group>
          <group group_id="O3">
            <title>MEDI0382 200 mcg</title>
            <description>MEDI0382 mid dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
          </group>
          <group group_id="O4">
            <title>MEDI0382 300 mcg</title>
            <description>MEDI0382 high dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change in Body Weight</title>
          <description>To assess the effect of 100, 200, 300 μg of cotadutide on body weight versus placebo</description>
          <population>ITT population</population>
          <units>percentage</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="112"/>
                <count group_id="O2" value="100"/>
                <count group_id="O3" value="256"/>
                <count group_id="O4" value="256"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.70" lower_limit="-1.44" upper_limit="0.04"/>
                    <measurement group_id="O2" value="-2.70" lower_limit="-3.49" upper_limit="-1.91"/>
                    <measurement group_id="O3" value="-3.47" lower_limit="-3.95" upper_limit="-2.98"/>
                    <measurement group_id="O4" value="-4.33" lower_limit="-4.82" upper_limit="-3.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-2.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.08</ci_lower_limit>
            <ci_upper_limit>-0.91</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-2.76</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.65</ci_lower_limit>
            <ci_upper_limit>-1.87</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-3.62</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.51</ci_lower_limit>
            <ci_upper_limit>-2.73</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in HbA1c</title>
        <description>To assess the effect of 100, 200, 300 μg of cotadutide on HbA1c versus placebo</description>
        <time_frame>from baseline to 26 weeks and 54 weeks</time_frame>
        <population>ITT population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
          </group>
          <group group_id="O2">
            <title>MEDI0382 100 mcg</title>
            <description>MEDI0382 low dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
          </group>
          <group group_id="O3">
            <title>MEDI0382 200 mcg</title>
            <description>MEDI0382 mid dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
          </group>
          <group group_id="O4">
            <title>MEDI0382 300 mcg</title>
            <description>MEDI0382 high dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
          </group>
        </group_list>
        <measure>
          <title>Change in HbA1c</title>
          <description>To assess the effect of 100, 200, 300 μg of cotadutide on HbA1c versus placebo</description>
          <population>ITT population</population>
          <units>percentage</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="112"/>
                <count group_id="O2" value="100"/>
                <count group_id="O3" value="256"/>
                <count group_id="O4" value="256"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>from baseline to 26 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="112"/>
                    <count group_id="O2" value="98"/>
                    <count group_id="O3" value="252"/>
                    <count group_id="O4" value="252"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.40" lower_limit="-0.58" upper_limit="-0.22"/>
                    <measurement group_id="O2" value="-1.06" lower_limit="-1.25" upper_limit="-0.87"/>
                    <measurement group_id="O3" value="-1.22" lower_limit="-1.34" upper_limit="-1.10"/>
                    <measurement group_id="O4" value="-1.12" lower_limit="-1.24" upper_limit="-1.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>from baseline to 54 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="112"/>
                    <count group_id="O2" value="98"/>
                    <count group_id="O3" value="252"/>
                    <count group_id="O4" value="252"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.44" lower_limit="-0.63" upper_limit="-0.24"/>
                    <measurement group_id="O2" value="-0.96" lower_limit="-1.16" upper_limit="-0.75"/>
                    <measurement group_id="O3" value="-1.06" lower_limit="-1.19" upper_limit="-0.93"/>
                    <measurement group_id="O4" value="-1.01" lower_limit="-1.14" upper_limit="-0.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 26</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.66</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.92</ci_lower_limit>
            <ci_upper_limit>-0.40</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 26</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.81</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.03</ci_lower_limit>
            <ci_upper_limit>-0.60</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Week 26</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.72</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.94</ci_lower_limit>
            <ci_upper_limit>-0.51</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 54</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.52</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.80</ci_lower_limit>
            <ci_upper_limit>-0.24</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 54</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.63</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.86</ci_lower_limit>
            <ci_upper_limit>-0.39</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Week 54</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.57</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.80</ci_lower_limit>
            <ci_upper_limit>-0.34</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving an HbA1c Target &lt; 7.0%</title>
        <description>To assess the effect of 100, 200, and 300 μg of cotadutide on percentage of participants achieving an HbA1c target of &lt;7% versus placebo</description>
        <time_frame>after 14, 26, and 54 weeks</time_frame>
        <population>Intent-to-Treat (ITT) population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
          </group>
          <group group_id="O2">
            <title>MEDI0382 100 mcg</title>
            <description>MEDI0382 low dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
          </group>
          <group group_id="O3">
            <title>MEDI0382 200 mcg</title>
            <description>MEDI0382 mid dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
          </group>
          <group group_id="O4">
            <title>MEDI0382 300 mcg</title>
            <description>MEDI0382 high dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving an HbA1c Target &lt; 7.0%</title>
          <description>To assess the effect of 100, 200, and 300 μg of cotadutide on percentage of participants achieving an HbA1c target of &lt;7% versus placebo</description>
          <population>Intent-to-Treat (ITT) population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="112"/>
                <count group_id="O2" value="100"/>
                <count group_id="O3" value="256"/>
                <count group_id="O4" value="256"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>after 14 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="112"/>
                    <count group_id="O2" value="98"/>
                    <count group_id="O3" value="252"/>
                    <count group_id="O4" value="252"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="50"/>
                    <measurement group_id="O3" value="143"/>
                    <measurement group_id="O4" value="143"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>after 26 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="112"/>
                    <count group_id="O2" value="98"/>
                    <count group_id="O3" value="252"/>
                    <count group_id="O4" value="252"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="48"/>
                    <measurement group_id="O3" value="139"/>
                    <measurement group_id="O4" value="143"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>after 54 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="112"/>
                    <count group_id="O2" value="98"/>
                    <count group_id="O3" value="252"/>
                    <count group_id="O4" value="252"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="52"/>
                    <measurement group_id="O3" value="125"/>
                    <measurement group_id="O4" value="128"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 14</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio, log</param_type>
            <param_value>6.67</param_value>
            <ci_percent>92</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.34</ci_lower_limit>
            <ci_upper_limit>13.30</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 14</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio, log</param_type>
            <param_value>9.95</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>5.39</ci_lower_limit>
            <ci_upper_limit>18.36</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Week 14</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio, log</param_type>
            <param_value>8.52</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>4.65</ci_lower_limit>
            <ci_upper_limit>15.61</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 26</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio, log</param_type>
            <param_value>3.74</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.98</ci_lower_limit>
            <ci_upper_limit>7.03</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 26</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio, log</param_type>
            <param_value>5.40</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.13</ci_lower_limit>
            <ci_upper_limit>9.34</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Week 26</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio, log</param_type>
            <param_value>5.20</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.02</ci_lower_limit>
            <ci_upper_limit>8.97</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 54</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio, log</param_type>
            <param_value>4.94</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.61</ci_lower_limit>
            <ci_upper_limit>9.36</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 54</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio, log</param_type>
            <param_value>4.55</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.62</ci_lower_limit>
            <ci_upper_limit>7.89</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Week 54</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio, log</param_type>
            <param_value>4.34</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.51</ci_lower_limit>
            <ci_upper_limit>7.51</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change in Body Weight</title>
        <description>To assess the effect of 100, 200, and 300 μg of cotadutide on body weight versus placebo</description>
        <time_frame>from baseline to 26 weeks and 54 weeks</time_frame>
        <population>ITT population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
          </group>
          <group group_id="O2">
            <title>MEDI0382 100 mcg</title>
            <description>MEDI0382 low dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
          </group>
          <group group_id="O3">
            <title>MEDI0382 200 mcg</title>
            <description>MEDI0382 mid dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
          </group>
          <group group_id="O4">
            <title>MEDI0382 300 mcg</title>
            <description>MEDI0382 high dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change in Body Weight</title>
          <description>To assess the effect of 100, 200, and 300 μg of cotadutide on body weight versus placebo</description>
          <population>ITT population</population>
          <units>percentage</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="112"/>
                <count group_id="O2" value="100"/>
                <count group_id="O3" value="256"/>
                <count group_id="O4" value="256"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>from baseline to 26 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="112"/>
                    <count group_id="O2" value="98"/>
                    <count group_id="O3" value="253"/>
                    <count group_id="O4" value="250"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.14" lower_limit="-1.99" upper_limit="-0.29"/>
                    <measurement group_id="O2" value="-3.23" lower_limit="-4.13" upper_limit="-2.32"/>
                    <measurement group_id="O3" value="-3.94" lower_limit="-4.51" upper_limit="-3.38"/>
                    <measurement group_id="O4" value="-4.60" lower_limit="-5.17" upper_limit="-4.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>from baseline to 54 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="112"/>
                    <count group_id="O2" value="98"/>
                    <count group_id="O3" value="253"/>
                    <count group_id="O4" value="250"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.84" lower_limit="-1.82" upper_limit="0.14"/>
                    <measurement group_id="O2" value="-3.27" lower_limit="-4.32" upper_limit="-2.22"/>
                    <measurement group_id="O3" value="-3.08" lower_limit="-3.73" upper_limit="-2.43"/>
                    <measurement group_id="O4" value="-4.16" lower_limit="-4.81" upper_limit="-3.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 26</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-2.09</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.32</ci_lower_limit>
            <ci_upper_limit>-0.85</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 26</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-2.80</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.82</ci_lower_limit>
            <ci_upper_limit>-1.79</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Week 26</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-3.46</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.48</ci_lower_limit>
            <ci_upper_limit>-2.44</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 54</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-2.43</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.86</ci_lower_limit>
            <ci_upper_limit>-1.00</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 54</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-2.24</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.41</ci_lower_limit>
            <ci_upper_limit>-1.06</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Week 54</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-3.32</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.49</ci_lower_limit>
            <ci_upper_limit>-2.14</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Change in Body Weight</title>
        <description>To assess the effect of 100, 200, 300 μg of cotadutide on body weight versus placebo</description>
        <time_frame>from baseline to 14 weeks, 26 weeks and 54 weeks</time_frame>
        <population>ITT population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
          </group>
          <group group_id="O2">
            <title>MEDI0382 100 mcg</title>
            <description>MEDI0382 low dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
          </group>
          <group group_id="O3">
            <title>MEDI0382 200 mcg</title>
            <description>MEDI0382 mid dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
          </group>
          <group group_id="O4">
            <title>MEDI0382 300 mcg</title>
            <description>MEDI0382 high dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change in Body Weight</title>
          <description>To assess the effect of 100, 200, 300 μg of cotadutide on body weight versus placebo</description>
          <population>ITT population</population>
          <units>kg</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="112"/>
                <count group_id="O2" value="100"/>
                <count group_id="O3" value="256"/>
                <count group_id="O4" value="256"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>from baseline to 14 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="108"/>
                    <count group_id="O2" value="94"/>
                    <count group_id="O3" value="248"/>
                    <count group_id="O4" value="245"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.71" lower_limit="-1.44" upper_limit="0.03"/>
                    <measurement group_id="O2" value="-2.66" lower_limit="-3.45" upper_limit="-1.87"/>
                    <measurement group_id="O3" value="-3.45" lower_limit="-3.94" upper_limit="-2.97"/>
                    <measurement group_id="O4" value="-4.42" lower_limit="-4.91" upper_limit="-3.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>from baseline to 26 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="112"/>
                    <count group_id="O2" value="98"/>
                    <count group_id="O3" value="253"/>
                    <count group_id="O4" value="250"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.20" lower_limit="-2.06" upper_limit="-0.34"/>
                    <measurement group_id="O2" value="-3.20" lower_limit="-4.13" upper_limit="-2.28"/>
                    <measurement group_id="O3" value="-3.94" lower_limit="-4.52" upper_limit="-3.37"/>
                    <measurement group_id="O4" value="-4.75" lower_limit="-5.33" upper_limit="-4.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>from baseline to 54 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="112"/>
                    <count group_id="O2" value="98"/>
                    <count group_id="O3" value="253"/>
                    <count group_id="O4" value="250"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.94" lower_limit="-1.94" upper_limit="0.07"/>
                    <measurement group_id="O2" value="-3.20" lower_limit="-4.28" upper_limit="-2.12"/>
                    <measurement group_id="O3" value="-3.09" lower_limit="-3.77" upper_limit="-2.42"/>
                    <measurement group_id="O4" value="-4.35" lower_limit="-5.03" upper_limit="-3.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 14</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-1.95</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.03</ci_lower_limit>
            <ci_upper_limit>-0.87</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 14</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-2.75</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.63</ci_lower_limit>
            <ci_upper_limit>-1.86</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Week 14</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-3.71</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.60</ci_lower_limit>
            <ci_upper_limit>-2.82</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 26</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.002</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-2.01</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.27</ci_lower_limit>
            <ci_upper_limit>-0.74</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 26</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-2.74</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.78</ci_lower_limit>
            <ci_upper_limit>-1.71</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Week 26</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-3.55</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.59</ci_lower_limit>
            <ci_upper_limit>-2.52</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 54</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.003</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-2.27</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.74</ci_lower_limit>
            <ci_upper_limit>-0.79</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 54</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-2.16</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.37</ci_lower_limit>
            <ci_upper_limit>-0.95</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Week 54</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-3.42</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.63</ci_lower_limit>
            <ci_upper_limit>-2.20</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change in Body Weight Versus Active Comparator</title>
        <description>To assess the effect of 100, 200, and 300 μg of cotadutide on body weight versus liraglutide 1.8 mg once daily</description>
        <time_frame>from baseline to 14 weeks, 26 weeks and 54 weeks</time_frame>
        <population>ITT population</population>
        <group_list>
          <group group_id="O1">
            <title>Liraglutide</title>
            <description>Liraglutide / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
          </group>
          <group group_id="O2">
            <title>MEDI0382 100 mcg</title>
            <description>MEDI0382 low dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
          </group>
          <group group_id="O3">
            <title>MEDI0382 200 mcg</title>
            <description>MEDI0382 mid dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
          </group>
          <group group_id="O4">
            <title>MEDI0382 300 mcg</title>
            <description>MEDI0382 high dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change in Body Weight Versus Active Comparator</title>
          <description>To assess the effect of 100, 200, and 300 μg of cotadutide on body weight versus liraglutide 1.8 mg once daily</description>
          <population>ITT population</population>
          <units>percentage</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="110"/>
                <count group_id="O2" value="100"/>
                <count group_id="O3" value="256"/>
                <count group_id="O4" value="256"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Percent change at 14 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="94"/>
                    <count group_id="O3" value="248"/>
                    <count group_id="O4" value="245"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.40" lower_limit="-4.14" upper_limit="-2.65"/>
                    <measurement group_id="O2" value="-2.70" lower_limit="-3.49" upper_limit="-1.91"/>
                    <measurement group_id="O3" value="-3.47" lower_limit="-3.95" upper_limit="-2.98"/>
                    <measurement group_id="O4" value="-4.33" lower_limit="-4.82" upper_limit="-3.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent change at 26 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="110"/>
                    <count group_id="O2" value="98"/>
                    <count group_id="O3" value="253"/>
                    <count group_id="O4" value="250"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.12" lower_limit="-4.98" upper_limit="-3.27"/>
                    <measurement group_id="O2" value="-3.23" lower_limit="-4.13" upper_limit="-2.32"/>
                    <measurement group_id="O3" value="-3.94" lower_limit="-4.51" upper_limit="-3.38"/>
                    <measurement group_id="O4" value="-4.60" lower_limit="-5.17" upper_limit="-4.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent change at 54 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="110"/>
                    <count group_id="O2" value="98"/>
                    <count group_id="O3" value="253"/>
                    <count group_id="O4" value="250"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.20" lower_limit="-4.19" upper_limit="-2.21"/>
                    <measurement group_id="O2" value="-3.27" lower_limit="-4.32" upper_limit="-2.22"/>
                    <measurement group_id="O3" value="-3.08" lower_limit="-3.73" upper_limit="-2.43"/>
                    <measurement group_id="O4" value="-4.16" lower_limit="-4.81" upper_limit="-3.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Percent change at Week 14</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.211</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.70</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.39</ci_lower_limit>
            <ci_upper_limit>1.79</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Percent change at Week 14</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.881</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.07</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.96</ci_lower_limit>
            <ci_upper_limit>0.83</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Percent change at Week 14</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.042</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.93</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.82</ci_lower_limit>
            <ci_upper_limit>-0.04</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Percent change at Week 26</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.158</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.90</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.35</ci_lower_limit>
            <ci_upper_limit>2.14</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Percent change at Week 26</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.734</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.18</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.85</ci_lower_limit>
            <ci_upper_limit>1.20</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Percent change at Week 26</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.357</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.48</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.51</ci_lower_limit>
            <ci_upper_limit>0.54</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Percent change at Week 54</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.921</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.07</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.51</ci_lower_limit>
            <ci_upper_limit>1.37</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Percent change at Week 54</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.847</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.12</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.07</ci_lower_limit>
            <ci_upper_limit>1.30</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Percent change at Week 54</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.112</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.96</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.15</ci_lower_limit>
            <ci_upper_limit>0.22</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Change in Body Weight Versus Active Comparator</title>
        <description>To assess the effect of 100, 200, and 300 μg of cotadutide on body weight versus liraglutide 1.8 mg once daily</description>
        <time_frame>from baseline to 14 weeks, 26 weeks and 54 weeks</time_frame>
        <population>ITT population</population>
        <group_list>
          <group group_id="O1">
            <title>Liraglutide</title>
            <description>Liraglutide / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
          </group>
          <group group_id="O2">
            <title>MEDI0382 100 mcg</title>
            <description>MEDI0382 low dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
          </group>
          <group group_id="O3">
            <title>MEDI0382 200 mcg</title>
            <description>MEDI0382 mid dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
          </group>
          <group group_id="O4">
            <title>MEDI0382 300 mcg</title>
            <description>MEDI0382 high dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change in Body Weight Versus Active Comparator</title>
          <description>To assess the effect of 100, 200, and 300 μg of cotadutide on body weight versus liraglutide 1.8 mg once daily</description>
          <population>ITT population</population>
          <units>kg</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="110"/>
                <count group_id="O2" value="100"/>
                <count group_id="O3" value="256"/>
                <count group_id="O4" value="256"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Absolute change at 14 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="94"/>
                    <count group_id="O3" value="248"/>
                    <count group_id="O4" value="245"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.25" lower_limit="-4.00" upper_limit="-2.51"/>
                    <measurement group_id="O2" value="-2.66" lower_limit="-3.45" upper_limit="-1.87"/>
                    <measurement group_id="O3" value="-3.45" lower_limit="-3.94" upper_limit="-2.97"/>
                    <measurement group_id="O4" value="-4.42" lower_limit="-4.91" upper_limit="-3.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Absolute change at 26 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="110"/>
                    <count group_id="O2" value="98"/>
                    <count group_id="O3" value="253"/>
                    <count group_id="O4" value="250"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.90" lower_limit="-4.77" upper_limit="-3.03"/>
                    <measurement group_id="O2" value="-3.20" lower_limit="-4.13" upper_limit="-2.28"/>
                    <measurement group_id="O3" value="-3.94" lower_limit="-4.52" upper_limit="-3.37"/>
                    <measurement group_id="O4" value="-4.75" lower_limit="-5.33" upper_limit="-4.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Absolute change at 54 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="110"/>
                    <count group_id="O2" value="98"/>
                    <count group_id="O3" value="253"/>
                    <count group_id="O4" value="250"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.94" lower_limit="-3.96" upper_limit="-1.92"/>
                    <measurement group_id="O2" value="-3.20" lower_limit="-4.28" upper_limit="-2.12"/>
                    <measurement group_id="O3" value="-3.09" lower_limit="-3.77" upper_limit="-2.42"/>
                    <measurement group_id="O4" value="-4.35" lower_limit="-5.03" upper_limit="-3.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Absolute change at Week 14</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.284</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.59</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.49</ci_lower_limit>
            <ci_upper_limit>1.68</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Absolute change at Week 14</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.658</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.20</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.09</ci_lower_limit>
            <ci_upper_limit>0.69</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Absolute change at Week 14</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.010</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-1.17</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.06</ci_lower_limit>
            <ci_upper_limit>-0.27</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Absolute change at Week 26</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.279</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.70</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.57</ci_lower_limit>
            <ci_upper_limit>1.97</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Absolute change at Week 26</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.940</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.08</ci_lower_limit>
            <ci_upper_limit>1.00</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Absolute change at Week 26</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.110</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.85</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.89</ci_lower_limit>
            <ci_upper_limit>0.19</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Absolute change at Week 54</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.730</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.26</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.74</ci_lower_limit>
            <ci_upper_limit>1.22</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Absolute change at Week 54</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.804</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.15</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.38</ci_lower_limit>
            <ci_upper_limit>1.07</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Absolute change at Week 54</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.023</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-1.41</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.63</ci_lower_limit>
            <ci_upper_limit>-0.19</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving Weight Loss of ≥5% and ≥10%</title>
        <description>To assess the effect of 100, 200, and 300 μg of cotadutide on percentage of subjects achieving weight loss of ≥5% and ≥10% versus placebo</description>
        <time_frame>after 14 weeks, 26 weeks and 54 weeks</time_frame>
        <population>ITT population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
          </group>
          <group group_id="O2">
            <title>MEDI0382 100 mcg</title>
            <description>MEDI0382 low dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
          </group>
          <group group_id="O3">
            <title>MEDI0382 200 mcg</title>
            <description>MEDI0382 mid dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
          </group>
          <group group_id="O4">
            <title>MEDI0382 300 mcg</title>
            <description>MEDI0382 high dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Weight Loss of ≥5% and ≥10%</title>
          <description>To assess the effect of 100, 200, and 300 μg of cotadutide on percentage of subjects achieving weight loss of ≥5% and ≥10% versus placebo</description>
          <population>ITT population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="112"/>
                <count group_id="O2" value="100"/>
                <count group_id="O3" value="256"/>
                <count group_id="O4" value="256"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Participants with weight loss ≥5% at Wk 14 (LOCF)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="108"/>
                    <count group_id="O2" value="94"/>
                    <count group_id="O3" value="248"/>
                    <count group_id="O4" value="245"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="18"/>
                    <measurement group_id="O3" value="65"/>
                    <measurement group_id="O4" value="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with weight loss ≥5% at Wk 26 (LOCF)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="112"/>
                    <count group_id="O2" value="98"/>
                    <count group_id="O3" value="253"/>
                    <count group_id="O4" value="250"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="28"/>
                    <measurement group_id="O3" value="76"/>
                    <measurement group_id="O4" value="110"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with weight loss ≥5% at Wk 54 (LOCF)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="112"/>
                    <count group_id="O2" value="98"/>
                    <count group_id="O3" value="253"/>
                    <count group_id="O4" value="250"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="34"/>
                    <measurement group_id="O3" value="71"/>
                    <measurement group_id="O4" value="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with weight loss ≥10% at Wk 14 (LOCF)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="108"/>
                    <count group_id="O2" value="94"/>
                    <count group_id="O3" value="248"/>
                    <count group_id="O4" value="245"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="15"/>
                    <measurement group_id="O4" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with weight loss ≥10% at Wk 26 (LOCF)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="112"/>
                    <count group_id="O2" value="98"/>
                    <count group_id="O3" value="253"/>
                    <count group_id="O4" value="250"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="28"/>
                    <measurement group_id="O4" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with weight loss ≥10% at Wk 54 (LOCF)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="112"/>
                    <count group_id="O2" value="98"/>
                    <count group_id="O3" value="253"/>
                    <count group_id="O4" value="250"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="21"/>
                    <measurement group_id="O4" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>weight loss &gt;=5% at Week 14</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio, log</param_type>
            <param_value>8.37</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.38</ci_lower_limit>
            <ci_upper_limit>29.43</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>weight loss &gt;=5% at Week 14</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio, log</param_type>
            <param_value>12.46</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.82</ci_lower_limit>
            <ci_upper_limit>40.64</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>weight loss &gt;=5% at Week 14</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio, log</param_type>
            <param_value>21.26</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>6.55</ci_lower_limit>
            <ci_upper_limit>68.97</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>weight loss &gt;=5% at Week 26</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio, log</param_type>
            <param_value>3.68</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.72</ci_lower_limit>
            <ci_upper_limit>7.89</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>weight loss &gt;=5% at Week 26</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio, log</param_type>
            <param_value>3.95</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.00</ci_lower_limit>
            <ci_upper_limit>7.78</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>weight loss &gt;=5% at Week 26</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio, log</param_type>
            <param_value>7.28</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.72</ci_lower_limit>
            <ci_upper_limit>14.24</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>weight loss &gt;=5% at Week 54</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio, log</param_type>
            <param_value>3.71</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.84</ci_lower_limit>
            <ci_upper_limit>7.45</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>weight loss &gt;=5% at Week 54</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.002</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio, log</param_type>
            <param_value>2.73</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.46</ci_lower_limit>
            <ci_upper_limit>5.09</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>weight loss &gt;=5% at Week 54</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Odds Ratio, log</param_type>
            <param_value>4.48</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.42</ci_lower_limit>
            <ci_upper_limit>8.30</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>weight loss &gt;=10% at Week 26</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.048</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio, log</param_type>
            <param_value>8.47</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.02</ci_lower_limit>
            <ci_upper_limit>70.17</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>weight loss &gt;=10% at Week 26</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.010</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio, log</param_type>
            <param_value>13.81</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.85</ci_lower_limit>
            <ci_upper_limit>102.91</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>weight loss &gt;=10% at Week 26</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.012</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio, log</param_type>
            <param_value>13.09</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.75</ci_lower_limit>
            <ci_upper_limit>97.68</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>weight loss &gt;=10% at Week 54</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.013</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio, log</param_type>
            <param_value>6.92</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.49</ci_lower_limit>
            <ci_upper_limit>32.07</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>weight loss &gt;=10% at Week 54</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.032</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio, log</param_type>
            <param_value>4.98</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.15</ci_lower_limit>
            <ci_upper_limit>21.60</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>weight loss &gt;=10% at Week 54</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.005</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio, log</param_type>
            <param_value>7.91</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.86</ci_lower_limit>
            <ci_upper_limit>33.64</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Rescued or Discontinued for Lack of Glycaemic Control</title>
        <description>To assess the effect of 100, 200, and 300 μg of cotadutide on the requirement for additional blood glucose-lowering therapies versus placebo</description>
        <time_frame>at 14 weeks, 26 weeks and 54 weeks</time_frame>
        <population>ITT population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
          </group>
          <group group_id="O2">
            <title>MEDI0382 100 mcg</title>
            <description>MEDI0382 low dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
          </group>
          <group group_id="O3">
            <title>MEDI0382 200 mcg</title>
            <description>MEDI0382 mid dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
          </group>
          <group group_id="O4">
            <title>MEDI0382 300 mcg</title>
            <description>MEDI0382 high dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Rescued or Discontinued for Lack of Glycaemic Control</title>
          <description>To assess the effect of 100, 200, and 300 μg of cotadutide on the requirement for additional blood glucose-lowering therapies versus placebo</description>
          <population>ITT population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="112"/>
                <count group_id="O2" value="100"/>
                <count group_id="O3" value="256"/>
                <count group_id="O4" value="256"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>received rescue medication at 14 wks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>received rescue medication at 26 wks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>received rescue medication at 54 wks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="26"/>
                    <measurement group_id="O4" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>discontinued study IP at 14 wks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>discontinued study IP at 26 wks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>discontinued study IP at 54 wks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>received rescue medication at 14 wks</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.024</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio, log</param_type>
            <param_value>0.09</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.01</ci_lower_limit>
            <ci_upper_limit>0.73</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>received rescue medication at 14 wks</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio, log</param_type>
            <param_value>0.11</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.03</ci_lower_limit>
            <ci_upper_limit>0.40</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>received rescue medication at 14 wks</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio, log</param_type>
            <param_value>0.07</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.02</ci_lower_limit>
            <ci_upper_limit>0.33</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>received rescue medication at 26 wks</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.002</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio, log</param_type>
            <param_value>0.14</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.04</ci_lower_limit>
            <ci_upper_limit>0.48</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>received rescue medication at 26 wks</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio, log</param_type>
            <param_value>0.14</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.06</ci_lower_limit>
            <ci_upper_limit>0.34</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>received rescue medication at 26 wks</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio, log</param_type>
            <param_value>0.11</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.04</ci_lower_limit>
            <ci_upper_limit>0.28</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>received rescue medication at 54 wks</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio, log</param_type>
            <param_value>0.24</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.11</ci_lower_limit>
            <ci_upper_limit>0.53</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>received rescue medication at 54 wks</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio, log</param_type>
            <param_value>0.24</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.13</ci_lower_limit>
            <ci_upper_limit>0.44</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>received rescue medication at 54 wks</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio, log</param_type>
            <param_value>0.22</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.12</ci_lower_limit>
            <ci_upper_limit>0.41</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>discontinued IP at 14 wks</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.216</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio, log</param_type>
            <param_value>0.22</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.02</ci_lower_limit>
            <ci_upper_limit>2.43</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>discontinued IP at 26 wks</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.253</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio, log</param_type>
            <param_value>0.28</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.03</ci_lower_limit>
            <ci_upper_limit>2.52</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>discontinued IP at 26 wks</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.079</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio, log</param_type>
            <param_value>0.21</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.04</ci_lower_limit>
            <ci_upper_limit>1.19</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>discontinued IP at 54 wks</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.252</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio, log</param_type>
            <param_value>0.27</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.03</ci_lower_limit>
            <ci_upper_limit>2.50</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>discontinued IP at 54 wks</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.143</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio, log</param_type>
            <param_value>0.32</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.07</ci_lower_limit>
            <ci_upper_limit>1.47</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetic (PK) Endpoint: Trough Plasma Concentration (Cmin)</title>
        <description>To characterise the PK profile of 100, 200, and 300 μg of cotadutide</description>
        <time_frame>Time points at which outcome measure were assessed for plasma concentration were Weeks 1,2,6,10,14,18,22,26, and 54</time_frame>
        <population>Per-protocol population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
          </group>
          <group group_id="O2">
            <title>MEDI0382 100 mcg</title>
            <description>MEDI0382 low dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
          </group>
          <group group_id="O3">
            <title>MEDI0382 200 mcg</title>
            <description>MEDI0382 mid dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
          </group>
          <group group_id="O4">
            <title>MEDI0382 300 mcg</title>
            <description>MEDI0382 high dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetic (PK) Endpoint: Trough Plasma Concentration (Cmin)</title>
          <description>To characterise the PK profile of 100, 200, and 300 μg of cotadutide</description>
          <population>Per-protocol population</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="100"/>
                <count group_id="O3" value="256"/>
                <count group_id="O4" value="256"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="67"/>
                    <count group_id="O3" value="179"/>
                    <count group_id="O4" value="170"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="2.68" spread="1.27"/>
                    <measurement group_id="O3" value="2.76" spread="1.88"/>
                    <measurement group_id="O4" value="2.77" spread="1.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="69"/>
                    <count group_id="O3" value="180"/>
                    <count group_id="O4" value="168"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="2.66" spread="1.61"/>
                    <measurement group_id="O3" value="5.13" spread="3.23"/>
                    <measurement group_id="O4" value="5.18" spread="3.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="69"/>
                    <count group_id="O3" value="192"/>
                    <count group_id="O4" value="177"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="2.75" spread="1.44"/>
                    <measurement group_id="O3" value="5.20" spread="3.57"/>
                    <measurement group_id="O4" value="7.77" spread="4.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="71"/>
                    <count group_id="O3" value="181"/>
                    <count group_id="O4" value="172"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="3.18" spread="2.26"/>
                    <measurement group_id="O3" value="5.74" spread="4.23"/>
                    <measurement group_id="O4" value="8.23" spread="4.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="72"/>
                    <count group_id="O3" value="184"/>
                    <count group_id="O4" value="178"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="3.79" spread="4.05"/>
                    <measurement group_id="O3" value="6.50" spread="5.26"/>
                    <measurement group_id="O4" value="9.71" spread="7.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 18</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="69"/>
                    <count group_id="O3" value="180"/>
                    <count group_id="O4" value="169"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="4.58" spread="5.04"/>
                    <measurement group_id="O3" value="7.43" spread="6.43"/>
                    <measurement group_id="O4" value="10.8" spread="7.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="70"/>
                    <count group_id="O3" value="177"/>
                    <count group_id="O4" value="168"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="4.63" spread="4.28"/>
                    <measurement group_id="O3" value="8.07" spread="7.01"/>
                    <measurement group_id="O4" value="11.5" spread="9.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="69"/>
                    <count group_id="O3" value="183"/>
                    <count group_id="O4" value="167"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="4.39" spread="3.33"/>
                    <measurement group_id="O3" value="8.12" spread="7.31"/>
                    <measurement group_id="O4" value="12.9" spread="12.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 54</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="69"/>
                    <count group_id="O3" value="180"/>
                    <count group_id="O4" value="166"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="4.58" spread="3.89"/>
                    <measurement group_id="O3" value="8.99" spread="9.22"/>
                    <measurement group_id="O4" value="13.2" spread="14.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Immunogenicity Endpoint: Overall Antidrug Antibody (ADA) Incidence (Number and Percentage of Positive Partipants)</title>
        <description>To characterise the immunogenicity of 100, 200, and 300 μg of cotadutide</description>
        <time_frame>Baseline through 54-week treatment period and 28-day follow-up</time_frame>
        <population>As-treated population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
          </group>
          <group group_id="O2">
            <title>MEDI0382 100 mcg</title>
            <description>MEDI0382 low dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
          </group>
          <group group_id="O3">
            <title>MEDI0382 200 mcg</title>
            <description>MEDI0382 mid dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
          </group>
          <group group_id="O4">
            <title>MEDI0382 300 mcg</title>
            <description>MEDI0382 high dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
          </group>
        </group_list>
        <measure>
          <title>Immunogenicity Endpoint: Overall Antidrug Antibody (ADA) Incidence (Number and Percentage of Positive Partipants)</title>
          <description>To characterise the immunogenicity of 100, 200, and 300 μg of cotadutide</description>
          <population>As-treated population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="112"/>
                <count group_id="O2" value="100"/>
                <count group_id="O3" value="256"/>
                <count group_id="O4" value="256"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ADA positive at baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="111"/>
                    <count group_id="O2" value="98"/>
                    <count group_id="O3" value="250"/>
                    <count group_id="O4" value="249"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA incidence</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="111"/>
                    <count group_id="O2" value="97"/>
                    <count group_id="O3" value="248"/>
                    <count group_id="O4" value="250"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="55"/>
                    <measurement group_id="O3" value="152"/>
                    <measurement group_id="O4" value="155"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA positive post-baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="111"/>
                    <count group_id="O2" value="97"/>
                    <count group_id="O3" value="248"/>
                    <count group_id="O4" value="250"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="54"/>
                    <measurement group_id="O3" value="152"/>
                    <measurement group_id="O4" value="155"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Immunogenicity Endpoint: Median Titer of the Anti-Drug Antibodies (ADA) to MEDI0382 in the Positive Participants</title>
        <description>To characterise the immunogenicity of 100, 200, and 300 μg of cotadutide</description>
        <time_frame>Baseline through 54-week treatment period and 28-day follow-up</time_frame>
        <population>As-treated population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
          </group>
          <group group_id="O2">
            <title>MEDI0382 100 mcg</title>
            <description>MEDI0382 low dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
          </group>
          <group group_id="O3">
            <title>MEDI0382 200 mcg</title>
            <description>MEDI0382 mid dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
          </group>
          <group group_id="O4">
            <title>MEDI0382 300 mcg</title>
            <description>MEDI0382 high dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
          </group>
        </group_list>
        <measure>
          <title>Immunogenicity Endpoint: Median Titer of the Anti-Drug Antibodies (ADA) to MEDI0382 in the Positive Participants</title>
          <description>To characterise the immunogenicity of 100, 200, and 300 μg of cotadutide</description>
          <population>As-treated population</population>
          <units>titer</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="112"/>
                <count group_id="O2" value="100"/>
                <count group_id="O3" value="256"/>
                <count group_id="O4" value="256"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ADA positive at baseline, median titer</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="111"/>
                    <count group_id="O2" value="98"/>
                    <count group_id="O3" value="250"/>
                    <count group_id="O4" value="249"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" lower_limit="5" upper_limit="5"/>
                    <measurement group_id="O2" value="5.0" lower_limit="5" upper_limit="5"/>
                    <measurement group_id="O3" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O4" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA incidence, median of maximum titer</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="111"/>
                    <count group_id="O2" value="97"/>
                    <count group_id="O3" value="248"/>
                    <count group_id="O4" value="250"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" lower_limit="5" upper_limit="20"/>
                    <measurement group_id="O2" value="20.0" lower_limit="5" upper_limit="2560"/>
                    <measurement group_id="O3" value="20.0" lower_limit="5" upper_limit="640"/>
                    <measurement group_id="O4" value="20.0" lower_limit="5" upper_limit="5120"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA positive post-baseline, median of max. titer</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="111"/>
                    <count group_id="O2" value="97"/>
                    <count group_id="O3" value="248"/>
                    <count group_id="O4" value="250"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" lower_limit="5" upper_limit="20"/>
                    <measurement group_id="O2" value="20.0" lower_limit="5" upper_limit="2560"/>
                    <measurement group_id="O3" value="20.0" lower_limit="5" upper_limit="640"/>
                    <measurement group_id="O4" value="20.0" lower_limit="5" upper_limit="5120"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected from time of first IP dose throughout the 54-week treatment period and including the 28-day follow-up period. Serious AEs were recorded from the time of signature of informed consent.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Placebo / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
        </group>
        <group group_id="E2">
          <title>Liraglutide</title>
          <description>Liraglutide + Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
        </group>
        <group group_id="E3">
          <title>MEDI0382 100 mcg</title>
          <description>MEDI0382 low dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
        </group>
        <group group_id="E4">
          <title>MEDI0382 200 mcg</title>
          <description>MEDI0382 mid dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
        </group>
        <group group_id="E5">
          <title>MEDI0382 300 mcg</title>
          <description>MEDI0382 high dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 22</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="256"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="112"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="110"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="100"/>
                <counts group_id="E4" subjects_affected="33" subjects_at_risk="256"/>
                <counts group_id="E5" subjects_affected="20" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="256"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="256"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Aortic valve stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Arteriosclerosis coronary artery</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="256"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Atrioventricular block complete</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Cardiac failure chronic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="256"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Myocardial ischaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Silent myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Retinal detachment</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Retinal tear</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Colitis ulcerative</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Enterocutaneous fistula</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Gastric polyps</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="256"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Hiatus hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="256"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="256"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Irritable bowel syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="256"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Megacolon</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="256"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Retroperitoneal haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Impaired healing</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Gallbladder polyp</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="256"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Hepatic cirrhosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Acarodermatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Bacterial infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Chronic sinusitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="256"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Otitis media acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="100"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Postoperative wound infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Pyelonephritis chronic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="256"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Anastomotic leak</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Arterial bypass occlusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Concussion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="256"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Craniocerebral injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="256"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="256"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Post procedural fistula</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Spinal column injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Subcutaneous haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Tibia fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="256"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Upper limb fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="256"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic metabolic decompensation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthrofibrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Haematoma muscle</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="256"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Meniscal degeneration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="256"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Rotator cuff syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Acute leukaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Gastrointestinal stromal tumour</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Lymphoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Pancreatic carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="256"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Prostate cancer metastatic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Tongue neoplasm malignant stage unspecified</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Triple negative breast cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="256"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Diabetic neuropathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Haemorrhagic stroke</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Vertigo cns origin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="256"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic kidney disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Perinephritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Prerenal failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Urinary tract disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Acquired phimosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Uterine prolapse</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Dysphonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Pulmonary oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="256"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Vocal cord dysfunction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="256"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Hypertensive crisis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Peripheral arterial occlusive disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="256"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 22</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="45" subjects_at_risk="112"/>
                <counts group_id="E2" subjects_affected="36" subjects_at_risk="110"/>
                <counts group_id="E3" subjects_affected="51" subjects_at_risk="100"/>
                <counts group_id="E4" subjects_affected="159" subjects_at_risk="256"/>
                <counts group_id="E5" subjects_affected="164" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="112"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="110"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E4" events="10" subjects_affected="10" subjects_at_risk="256"/>
                <counts group_id="E5" events="14" subjects_affected="13" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="112"/>
                <counts group_id="E2" events="7" subjects_affected="4" subjects_at_risk="110"/>
                <counts group_id="E3" events="15" subjects_affected="13" subjects_at_risk="100"/>
                <counts group_id="E4" events="68" subjects_affected="49" subjects_at_risk="256"/>
                <counts group_id="E5" events="40" subjects_affected="28" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="112"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="110"/>
                <counts group_id="E3" events="13" subjects_affected="7" subjects_at_risk="100"/>
                <counts group_id="E4" events="26" subjects_affected="19" subjects_at_risk="256"/>
                <counts group_id="E5" events="38" subjects_affected="28" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Eructation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="100"/>
                <counts group_id="E4" events="17" subjects_affected="14" subjects_at_risk="256"/>
                <counts group_id="E5" events="15" subjects_affected="12" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="13" subjects_affected="12" subjects_at_risk="112"/>
                <counts group_id="E2" events="21" subjects_affected="17" subjects_at_risk="110"/>
                <counts group_id="E3" events="28" subjects_affected="23" subjects_at_risk="100"/>
                <counts group_id="E4" events="115" subjects_affected="85" subjects_at_risk="256"/>
                <counts group_id="E5" events="143" subjects_affected="105" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="112"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="110"/>
                <counts group_id="E3" events="12" subjects_affected="10" subjects_at_risk="100"/>
                <counts group_id="E4" events="66" subjects_affected="51" subjects_at_risk="256"/>
                <counts group_id="E5" events="58" subjects_affected="43" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="19" subjects_affected="15" subjects_at_risk="112"/>
                <counts group_id="E2" events="13" subjects_affected="11" subjects_at_risk="110"/>
                <counts group_id="E3" events="13" subjects_affected="11" subjects_at_risk="100"/>
                <counts group_id="E4" events="28" subjects_affected="22" subjects_at_risk="256"/>
                <counts group_id="E5" events="44" subjects_affected="28" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection viral</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="112"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E4" events="15" subjects_affected="13" subjects_at_risk="256"/>
                <counts group_id="E5" events="8" subjects_affected="7" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="112"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="110"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="100"/>
                <counts group_id="E4" events="17" subjects_affected="13" subjects_at_risk="256"/>
                <counts group_id="E5" events="9" subjects_affected="7" subjects_at_risk="256"/>
              </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="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="100"/>
                <counts group_id="E4" events="12" subjects_affected="12" subjects_at_risk="256"/>
                <counts group_id="E5" events="14" subjects_affected="14" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="112"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="110"/>
                <counts group_id="E3" events="8" subjects_affected="8" subjects_at_risk="100"/>
                <counts group_id="E4" events="12" subjects_affected="9" subjects_at_risk="256"/>
                <counts group_id="E5" events="9" subjects_affected="9" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="100"/>
                <counts group_id="E4" events="12" subjects_affected="11" subjects_at_risk="256"/>
                <counts group_id="E5" events="19" subjects_affected="15" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="110"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="100"/>
                <counts group_id="E4" events="18" subjects_affected="15" subjects_at_risk="256"/>
                <counts group_id="E5" events="23" subjects_affected="19" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The Principal Investigator shall provide AstraZeneca with copies of any materials relating to the Study, the Study Documentation, or the Developed Technologies that either Party intends to publish (or submit for publication) or make any presentations relating to, at least 60 days in advance of publication, submission or presentation.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>AstraZenenca Information Center</name_or_title>
      <organization>AstraZeneca</organization>
      <phone>1-877-240-9479</phone>
      <email>information.center@astrazeneca.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/NCT03235050
org study id: D5670C00004
nct id: NCT03235050
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study is designed to evaluate the dose range for MEDI0382 with respect to blood glucose
      control and weight loss effects, as well as to further explore the safety profile of MEDI0382
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomised, parallel, double-blind, placebo-controlled study with an open-label active comparator.
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
masking description: The study will be conducted in a double-blind fashion for MEDI0382 and placebo. The sponsor staff, the subjects, and the Investigators involved in the treatment of subjects or in the clinical evaluation of subjects will not be aware of the treatment received. Liraglutide will be provided in an open-label active comparator arm.
measure: Change in HbA1c
time frame: From baseline to 14 weeks
description: To assess the effect of 100, 200, 300 μg of cotadutide on HbA1c versus placebo
measure: Percent Change in Body Weight
time frame: From baseline to 14 weeks
description: To assess the effect of 100, 200, 300 μg of cotadutide on body weight versus placebo
measure: Change in HbA1c
time frame: from baseline to 26 weeks and 54 weeks
description: To assess the effect of 100, 200, 300 μg of cotadutide on HbA1c versus placebo
measure: Percentage of Participants Achieving an HbA1c Target < 7.0%
time frame: after 14, 26, and 54 weeks
description: To assess the effect of 100, 200, and 300 μg of cotadutide on percentage of participants achieving an HbA1c target of <7% versus placebo
measure: Percent Change in Body Weight
time frame: from baseline to 26 weeks and 54 weeks
description: To assess the effect of 100, 200, and 300 μg of cotadutide on body weight versus placebo
measure: Absolute Change in Body Weight
time frame: from baseline to 14 weeks, 26 weeks and 54 weeks
description: To assess the effect of 100, 200, 300 μg of cotadutide on body weight versus placebo
measure: Percent Change in Body Weight Versus Active Comparator
time frame: from baseline to 14 weeks, 26 weeks and 54 weeks
description: To assess the effect of 100, 200, and 300 μg of cotadutide on body weight versus liraglutide 1.8 mg once daily
measure: Absolute Change in Body Weight Versus Active Comparator
time frame: from baseline to 14 weeks, 26 weeks and 54 weeks
description: To assess the effect of 100, 200, and 300 μg of cotadutide on body weight versus liraglutide 1.8 mg once daily
measure: Percentage of Participants Achieving Weight Loss of ≥5% and ≥10%
time frame: after 14 weeks, 26 weeks and 54 weeks
description: To assess the effect of 100, 200, and 300 μg of cotadutide on percentage of subjects achieving weight loss of ≥5% and ≥10% versus placebo
measure: Percentage of Participants Rescued or Discontinued for Lack of Glycaemic Control
time frame: at 14 weeks, 26 weeks and 54 weeks
description: To assess the effect of 100, 200, and 300 μg of cotadutide on the requirement for additional blood glucose-lowering therapies versus placebo
measure: Pharmacokinetic (PK) Endpoint: Trough Plasma Concentration (Cmin)
time frame: Time points at which outcome measure were assessed for plasma concentration were Weeks 1,2,6,10,14,18,22,26, and 54
description: To characterise the PK profile of 100, 200, and 300 μg of cotadutide
measure: Immunogenicity Endpoint: Overall Antidrug Antibody (ADA) Incidence (Number and Percentage of Positive Partipants)
time frame: Baseline through 54-week treatment period and 28-day follow-up
description: To characterise the immunogenicity of 100, 200, and 300 μg of cotadutide
measure: Immunogenicity Endpoint: Median Titer of the Anti-Drug Antibodies (ADA) to MEDI0382 in the Positive Participants
time frame: Baseline through 54-week treatment period and 28-day follow-up
description: To characterise the immunogenicity of 100, 200, and 300 μg of cotadutide
arm group label: MEDI0382 low dose + Metformin
arm group type: Experimental
description: Drug: MEDI0382 low dose Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)
arm group label: MEDI0382 mid dose + Metformin
arm group type: Experimental
description: Drug: MEDI0382 mid dose Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)
arm group label: MEDI0382 high dose + Metformin
arm group type: Experimental
description: Drug: MEDI0382 high dose Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)
arm group label: Placebo + Metformin
arm group type: Placebo Comparator
description: Drug: Placebo Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)
arm group label: Liraglutide + Metformin
arm group type: Active Comparator
description: Drug: Liraglutide Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)
intervention type: Drug
intervention name: MEDI0382 low dose
description: Pharmaceutical form: solution Route of administration: subcutaneous
arm group label: MEDI0382 low dose + Metformin
intervention type: Drug
intervention name: MEDI0382 mid dose
description: Pharmaceutical form: solution Route of administration: subcutaneous
arm group label: MEDI0382 mid dose + Metformin
intervention type: Drug
intervention name: MEDI0382 high dose
description: Pharmaceutical form: solution Route of administration: subcutaneous
arm group label: MEDI0382 high dose + Metformin
intervention type: Drug
intervention name: Placebo
description: Pharmaceutical form: solution Route of administration: subcutaneous
arm group label: Placebo + Metformin
intervention type: Drug
intervention name: Liraglutide
description: Pharmaceutical form: solution Route of administration: subcutaneous
arm group label: Liraglutide + Metformin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 130 Years
healthy volunteers: No
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country: Bulgaria
country: Canada
country: Czechia
country: Germany
country: Mexico
country: Russian Federation
country: Slovakia
country: United States
country: Hungary
url: https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D5670C00004&amp;attachmentIdentifier=d3772b2d-e5a9-4fef-b796-e371735f6b2d&amp;fileName=D5670C00004_SAP_redacted.pdf&amp;versionIdentifier=
description: D5670C00004 SAP redacted
url: https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D5670C00004&amp;attachmentIdentifier=e91d84a4-416d-4262-aea8-98b99f6854c5&amp;fileName=D5670C00004_CSP_redacted.pdf&amp;versionIdentifier=
description: D5670C00004 CSP redacted
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Overweight
mesh term: Diabetes Mellitus, Type 2
mesh term: Liraglutide
provided document: 
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participant flow: 
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reported events: 
certain agreements: 
point of contact: 