<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/NCT03751007</url>
  </required_header>
  <id_info>
    <org_study_id>AG019-T1D-101</org_study_id>
    <secondary_id>2017-002871-24</secondary_id>
    <nct_id>NCT03751007</nct_id>
  </id_info>
  <brief_title>A Study to Assess the Safety and Tolerability of Different Doses of AG019 Administered Alone or in Combination With Teplizumab in Participants With Recent-onset Diagnosed Type 1 Diabetes (T1D)</brief_title>
  <official_title>A Prospective, Multi-center, Phase 1b/2a Study to Assess the Safety and Tolerability of Different Doses of AG019 Administered Alone or in Association With Teplizumab in Patients With Clinical Recent-onset Type 1 Diabetes Mellitus (T1D)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Precigen Actobio T1D, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Intrexon Actobiotics NV, d/b/a Precigen Actobio</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Precigen Actobio T1D, LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the safety and tolerability of different doses of&#xD;
      AG019 administered alone or in combination with teplizumab in participants with recent-onset&#xD;
      type 1 diabetes (T1D).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This Phase 1b/2a, multi-center study will be conducted in participants with clinical&#xD;
      recent-onset type 1 diabetes (T1D).&#xD;
&#xD;
      The primary objective of this study is to assess the safety and tolerability of different&#xD;
      doses of AG019 alone as well as AG019 in combination with teplizumab. The secondary&#xD;
      objectives of this study are: to obtain pharmacodynamic (PD) data of AG019 alone as well as&#xD;
      AG019 in combination with teplizumab; and to determine the potential presence of AG019 in&#xD;
      systemic circulation (safety - systemic exposure) and the presence of L. lactis bacteria in&#xD;
      fecal excretion (local exposure): Pharmacokinetic (PK) profile.&#xD;
&#xD;
      This study consists of 2 phases:&#xD;
&#xD;
      Phase 1b: this open-label part of the study will investigate the safety and tolerability of 2&#xD;
      different doses of AG019 in 2 age groups (18-40 years of age and 12-17 years of age).&#xD;
&#xD;
      Phase 2a: this randomized, double-blind part of the study will investigate the safety and&#xD;
      tolerability of AG019, in combination with teplizumab, in 2 age groups (18-40 years of age&#xD;
      and 12-17 years of age).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 24, 2018</start_date>
  <completion_date type="Actual">October 13, 2021</completion_date>
  <primary_completion_date type="Actual">October 13, 2021</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>The phase 1b part of the study will enroll 4 sequential AG019 cohorts of up to 6 participants, in ascending dose cohorts and descending age cohorts. All participants in these cohorts will be treated with AG019 in an open label fashion.&#xD;
The phase 2a part of the study will evaluate 2 cohorts of participants administered AG019 and teplizumab. The first 2 participants will be treated with active treatment in an open label fashion. Participants 3-12 will be randomized (4:1) to receive active treatment or placebo in a double-blind fashion.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>For the randomized participants in the combination cohorts, blinding will be accomplished by arranging for AG019 and placebo components as well as teplizumab and placebo components to have identical packaging.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Treatment-emergent Adverse Events (TEAE)</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Treatment-emergent adverse events assessed by the investigator, review of lab reports and information provided by the participant during site visits and/or participant diary with AG019 alone or with teplizumab</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>AG019 in Systemic Circulation</measure>
    <time_frame>Up to 3 months after initiation of the treatment</time_frame>
    <description>The presence of live L. lactis bacteria in blood will be assessed by plating</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>L. Lactis-secreted hPINS or hIL-10 in Systemic Circulation</measure>
    <time_frame>Up to 3 months after initiation of the treatment</time_frame>
    <description>The presence of L. lactis-secreted hPINS or hIL-10 in the blood will be assessed by ELISA (enzyme-linked immunosorbent assay)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AG019 in Feces</measure>
    <time_frame>Up to 8 days after completion of the treatment</time_frame>
    <description>The presence of L. lactis (live or dead) in feces will be assessed by Q-PCR (quantitative real-time polymerase chain reaction)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C-peptide Area Under the Concentration-time Curve (AUC) Calculated From a 2 Hour Mixed Meal Tolerance Test (MMTT) at 12 Months</measure>
    <time_frame>up to 12 months</time_frame>
    <description>MMTT-stimulated 2-hour C-peptide AUC was defined as the mean area under the C-peptide level time curve over the 2-hour period divided by the duration after a mixed-meal tolerance test.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Incidence of Treatment Emergent Adverse Events up to 12 Months</measure>
    <time_frame>Up to 12 months from screening</time_frame>
    <description>Incidence of all reported TEAE up to the 12-month follow-up visit. The TEAE are counted once within each patient on the preferred term level.</description>
  </other_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Diabetes type1</condition>
  <arm_group>
    <arm_group_label>AG019 Cohort 1 - Low Dose/Adults</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>AG019 Cohort 2 - High Dose/Adults</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>AG019 Cohort 3 - Low Dose/Adolescents</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>AG019 Cohort 4 - High Dose/Adolescents</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Combination Cohort 1 - Adults</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Combination Cohort 2 - Adolescents</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>AG019 - Low Dose</intervention_name>
    <description>Solid, orally administered capsule - 2 capsules per day for 1 day (single dose) or 8 weeks (repeat dose)</description>
    <arm_group_label>AG019 Cohort 1 - Low Dose/Adults</arm_group_label>
    <arm_group_label>AG019 Cohort 3 - Low Dose/Adolescents</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Teplizumab</intervention_name>
    <description>Daily IV infusions of Teplizumab during the first 12 days of AG019 treatment. Total cumulative dose is approximately 17mg (dose calculation based on body surface area).</description>
    <arm_group_label>Combination Cohort 1 - Adults</arm_group_label>
    <arm_group_label>Combination Cohort 2 - Adolescents</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo-AG019</intervention_name>
    <description>Formulated identically to AG019 with the active ingredient removed.</description>
    <arm_group_label>Combination Cohort 1 - Adults</arm_group_label>
    <arm_group_label>Combination Cohort 2 - Adolescents</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo-Teplizumab</intervention_name>
    <description>Formulated identically to teplizumab with the active ingredient removed.</description>
    <arm_group_label>Combination Cohort 1 - Adults</arm_group_label>
    <arm_group_label>Combination Cohort 2 - Adolescents</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>AG019 - High Dose</intervention_name>
    <description>Solid, orally administered capsule - 6 capsules per day for 1 day (single dose) or 8 weeks</description>
    <arm_group_label>AG019 Cohort 2 - High Dose/Adults</arm_group_label>
    <arm_group_label>AG019 Cohort 4 - High Dose/Adolescents</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>AG019 - High Dose</intervention_name>
    <description>Solid, orally administered capsule - 6 capsules per day for 8 weeks.</description>
    <arm_group_label>Combination Cohort 1 - Adults</arm_group_label>
    <arm_group_label>Combination Cohort 2 - Adolescents</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or non-pregnant, non-lactating females, 18 - 40 years of age (both inclusive) or&#xD;
             12-17 years of age (both inclusive)&#xD;
&#xD;
          -  Diagnosis of diabetes according to the American Diabetes Association (ADA) recommended&#xD;
             criteria&#xD;
&#xD;
          -  Evidence of auto-antibodies to at least 1 β-cell autoantigen&#xD;
&#xD;
          -  Stimulated C-peptide measured during 4h Mixed Meal tolerance Test (MMTT) &gt; 0.2 nmol/L&#xD;
&#xD;
          -  The first administration of AG019 should occur no later than 150 days post diagnosis&#xD;
             of diabetes&#xD;
&#xD;
          -  Body weight ≥ 33kg&#xD;
&#xD;
          -  Written informed consent obtained and documented (participant, parent, guardian as&#xD;
             applicable)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous history of serious cytokine release syndrome to teplizumab or other humanized&#xD;
             anti-CD3 monoclonal antibodies with no or minimal capacity to bind Fc receptors.&#xD;
             (Participants enrolled in the second phase of the trial in either Combination Cohort 1&#xD;
             or Combination Cohort 2, only)&#xD;
&#xD;
          -  Use of immunosuppressive or immunomodulatory therapies, including systemic steroids&#xD;
             within 1 month prior to randomization&#xD;
&#xD;
          -  Participation in another investigational drug trial within 12 weeks prior to the first&#xD;
             study drug intake and during participation in this study&#xD;
&#xD;
          -  History of recurrent infections, other autoimmune diseases, cardiac disease,&#xD;
             malignancy, or any other (chronic) medical condition which, in the investigator's&#xD;
             opinion, could compromise participant safety&#xD;
&#xD;
          -  Documented history of human immunodeficiency virus (HIV), Hepatitis Virus Type C&#xD;
             (HCV), Hepatitis Virus Type B (HBV) infection&#xD;
&#xD;
          -  Evidence of active infection with Epstein-Barr Virus (EBV) or cytomegalovirus (CMV)&#xD;
&#xD;
          -  Evidence of active or latent tuberculosis (TB)&#xD;
&#xD;
          -  Administration of anti-CD3 antibody in past year&#xD;
&#xD;
          -  Current therapy with any other anti-diabetic agents other than insulin (MDI, CSII or&#xD;
             analogue). Current or planned therapy with experimental (i.e., unapproved) insulin.&#xD;
             Patients on therapy for type 2 diabetes (e.g. metformin) should stop their therapy in&#xD;
             order to be eligible for study participation.&#xD;
&#xD;
          -  Use of medications known to influence glucose tolerance&#xD;
&#xD;
          -  Daily use of non-steroidal anti-inflammatory agents&#xD;
&#xD;
          -  Compromised GI mucosal integrity or motility, not attributable to T1D (i.e., recent&#xD;
             diarrhea, gluten sensitive enteropathy, inflammatory bowel disease, irritable bowel&#xD;
             syndrome), or current use of medications known to influence GI motility&#xD;
&#xD;
          -  Positive result of SARS-Cov2 PCR test at screening or within 3 days before&#xD;
             randomization&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chantal Mathieu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital of Leuven, Clinical and Experimental Endocrinology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kevan Herold, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale Center for Clinical Investigation; Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama, Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California, San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94158</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coastal Metabolic Research Centre</name>
      <address>
        <city>Ventura</city>
        <state>California</state>
        <zip>93003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale Center for Clinical Investigation</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06519</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of South Florida</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barry J Reiner, MD, LLC</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Minnesota Health</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55454</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Missouri-Kansas City School of Medicine</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanford Children's Specialty Clinic</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Diabetes and Endocrine Consultants</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37411</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Diabetes &amp; Endocrinology, P.A.</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78749</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Institute of Dallas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Benaroya Research Institute</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Brussel</name>
      <address>
        <city>Brussels</city>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Antwerpen</name>
      <address>
        <city>Edegem</city>
        <zip>2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>November 8, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <results_first_submitted>October 13, 2022</results_first_submitted>
  <results_first_submitted_qc>January 31, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">February 1, 2023</results_first_posted>
  <last_update_submitted>January 31, 2023</last_update_submitted>
  <last_update_submitted_qc>January 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_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>June 11, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/07/NCT03751007/Prot_000.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>May 28, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/07/NCT03751007/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>AG019 monotherapy cohorts: a total of 8 single dose patients and 19 repeat dose patients.&#xD;
AG019/teplizumab combination cohorts: a total of 18 patients</recruitment_details>
      <pre_assignment_details>18-40y, or 12-17y&#xD;
diagnosis of diabetes according to ADA criteria&#xD;
positive for at least 1 T1D autoantibody&#xD;
treatment to be started within 150 days of diagnosis&#xD;
greater than 0.2 nmol/L of C-peptide following mixed meal tolerance test&#xD;
No active infections</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>AG019 Cohort 1 - Low (Single) Dose/Adults</title>
          <description>AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 1 day (single dose)</description>
        </group>
        <group group_id="P2">
          <title>AG019 Cohort 1 - Low (Repeat) Dose/Adults</title>
          <description>AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 8 weeks (repeat dose)</description>
        </group>
        <group group_id="P3">
          <title>AG019 Cohort 2 - High (Single) Dose/Adults</title>
          <description>AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 1 day (single dose)</description>
        </group>
        <group group_id="P4">
          <title>AG019 Cohort 2 - High (Repeat) Dose/Adults</title>
          <description>AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose)</description>
        </group>
        <group group_id="P5">
          <title>AG019 Cohort 3 - Low (Single) Dose/Adolescents</title>
          <description>AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 1 day (single dose)</description>
        </group>
        <group group_id="P6">
          <title>AG019 Cohort 3 - Low (Repeat) Dose/Adolescents</title>
          <description>AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 8 weeks (repeat dose)</description>
        </group>
        <group group_id="P7">
          <title>AG019 Cohort 4 - High (Single) Dose/Adolescents</title>
          <description>AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 1 day (single dose)</description>
        </group>
        <group group_id="P8">
          <title>AG019 Cohort 4 - High (Repeat) Dose/Adolescents</title>
          <description>AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose)</description>
        </group>
        <group group_id="P9">
          <title>Combination Cohort 1 - Active AG019/Teplizumab - Adults</title>
          <description>Teplizumab: Daily IV infusions of Teplizumab during the first 12 days of AG019 treatment. Total cumulative dose is approximately 17mg (dose calculation based on body surface area).&#xD;
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks.</description>
        </group>
        <group group_id="P10">
          <title>Combination Cohort 1 - AG019-placebo/Teplizumab-placebo - Adults</title>
          <description>Placebo-AG019: Formulated identically to AG019 with the active ingredient removed.&#xD;
Placebo-Teplizumab: Formulated identically to teplizumab with the active ingredient removed.</description>
        </group>
        <group group_id="P11">
          <title>Combination Cohort 2 - Active AG019/Teplizumab - Adolescents</title>
          <description>Teplizumab: Daily IV infusions of Teplizumab during the first 12 days of AG019 treatment. Total cumulative dose is approximately 17mg (dose calculation based on body surface area).&#xD;
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks.</description>
        </group>
        <group group_id="P12">
          <title>Combination Cohort 2 - AG019-placebo/Teplizumab-placebo - Adolescents</title>
          <description>Placebo-AG019: Formulated identically to AG019 with the active ingredient removed.&#xD;
Placebo-Teplizumab: Formulated identically to teplizumab with the active ingredient removed.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="5"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="4"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="5"/>
                <participants group_id="P9" count="10"/>
                <participants group_id="P10" count="2"/>
                <participants group_id="P11" count="5"/>
                <participants group_id="P12" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="4"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="4"/>
                <participants group_id="P9" count="10"/>
                <participants group_id="P10" count="2"/>
                <participants group_id="P11" count="4"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="1"/>
                <participants group_id="P12" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>AG019 Cohort 1 - Low (Single) Dose/Adults</title>
          <description>AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 1 day (single dose)</description>
        </group>
        <group group_id="B2">
          <title>AG019 Cohort 1 - Low (Repeat) Dose/Adults</title>
          <description>AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 8 weeks (repeat dose)</description>
        </group>
        <group group_id="B3">
          <title>AG019 Cohort 2 - High (Single) Dose/Adults</title>
          <description>AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 1 day (single dose)</description>
        </group>
        <group group_id="B4">
          <title>AG019 Cohort 2 - High (Repeat) Dose/Adults</title>
          <description>AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose)</description>
        </group>
        <group group_id="B5">
          <title>AG019 Cohort 3 - Low (Single) Dose/Adolescents</title>
          <description>AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 1 day (single dose)</description>
        </group>
        <group group_id="B6">
          <title>AG019 Cohort 3 - Low (Repeat) Dose/Adolescents</title>
          <description>AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 8 weeks (repeat dose)</description>
        </group>
        <group group_id="B7">
          <title>AG019 Cohort 4 - High (Single) Dose/Adolescents</title>
          <description>AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 1 day (single dose)</description>
        </group>
        <group group_id="B8">
          <title>AG019 Cohort 4 - High (Repeat) Dose/Adolescents</title>
          <description>AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose)</description>
        </group>
        <group group_id="B9">
          <title>Combination Cohort 1 - Active AG019/Teplizumab - Adults</title>
          <description>Teplizumab: Daily IV infusions of Teplizumab during the first 12 days of AG019 treatment. Total cumulative dose is approximately 17mg (dose calculation based on body surface area).&#xD;
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks</description>
        </group>
        <group group_id="B10">
          <title>Combination Cohort 1 - AG019-placebo/Teplizumab-placebo - Adults</title>
          <description>Placebo-AG019: Formulated identically to AG019 with the active ingredient removed.&#xD;
Placebo-Teplizumab: Formulated identically to teplizumab with the active ingredient removed.</description>
        </group>
        <group group_id="B11">
          <title>Combination Cohort 2 - Active AG019/Teplizumab - Adolescents</title>
          <description>Teplizumab: Daily IV infusions of Teplizumab during the first 12 days of AG019 treatment. Total cumulative dose is approximately 17mg (dose calculation based on body surface area).&#xD;
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks</description>
        </group>
        <group group_id="B12">
          <title>Combination Cohort 2 - AG019-placebo/Teplizumab-placebo - Adolescents</title>
          <description>Placebo-AG019: Formulated identically to AG019 with the active ingredient removed.&#xD;
Placebo-Teplizumab: Formulated identically to teplizumab with the active ingredient removed.</description>
        </group>
        <group group_id="B13">
          <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="2"/>
            <count group_id="B2" value="5"/>
            <count group_id="B3" value="2"/>
            <count group_id="B4" value="5"/>
            <count group_id="B5" value="2"/>
            <count group_id="B6" value="4"/>
            <count group_id="B7" value="2"/>
            <count group_id="B8" value="5"/>
            <count group_id="B9" value="10"/>
            <count group_id="B10" value="2"/>
            <count group_id="B11" value="5"/>
            <count group_id="B12" value="1"/>
            <count group_id="B13" value="45"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2"/>
                    <count group_id="B2" value="5"/>
                    <count group_id="B3" value="2"/>
                    <count group_id="B4" value="5"/>
                    <count group_id="B5" value="2"/>
                    <count group_id="B6" value="4"/>
                    <count group_id="B7" value="2"/>
                    <count group_id="B8" value="5"/>
                    <count group_id="B9" value="10"/>
                    <count group_id="B10" value="2"/>
                    <count group_id="B11" value="5"/>
                    <count group_id="B12" value="1"/>
                    <count group_id="B13" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38.0" spread="5.7"/>
                    <measurement group_id="B2" value="26.0" spread="8.9"/>
                    <measurement group_id="B3" value="19.5" spread="2.1"/>
                    <measurement group_id="B4" value="22.0" spread="7.4"/>
                    <measurement group_id="B5" value="16.5" spread="0.7"/>
                    <measurement group_id="B6" value="14.0" spread="2.2"/>
                    <measurement group_id="B7" value="17.0" spread="0.0"/>
                    <measurement group_id="B8" value="14.0" spread="1.9"/>
                    <measurement group_id="B9" value="26.5" spread="6.7"/>
                    <measurement group_id="B10" value="29.0" spread="5.7"/>
                    <measurement group_id="B11" value="14.0" spread="1.1"/>
                    <measurement group_id="B12" value="12.0" spread="0.0"/>
                    <measurement group_id="B13" value="20.0" spread="8.6"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2"/>
                    <count group_id="B2" value="5"/>
                    <count group_id="B3" value="2"/>
                    <count group_id="B4" value="5"/>
                    <count group_id="B5" value="2"/>
                    <count group_id="B6" value="4"/>
                    <count group_id="B7" value="2"/>
                    <count group_id="B8" value="5"/>
                    <count group_id="B9" value="10"/>
                    <count group_id="B10" value="2"/>
                    <count group_id="B11" value="5"/>
                    <count group_id="B12" value="1"/>
                    <count group_id="B13" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="3"/>
                    <measurement group_id="B9" value="4"/>
                    <measurement group_id="B10" value="1"/>
                    <measurement group_id="B11" value="3"/>
                    <measurement group_id="B12" value="1"/>
                    <measurement group_id="B13" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="6"/>
                    <measurement group_id="B10" value="1"/>
                    <measurement group_id="B11" value="2"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2"/>
                    <count group_id="B2" value="5"/>
                    <count group_id="B3" value="2"/>
                    <count group_id="B4" value="5"/>
                    <count group_id="B5" value="2"/>
                    <count group_id="B6" value="4"/>
                    <count group_id="B7" value="2"/>
                    <count group_id="B8" value="5"/>
                    <count group_id="B9" value="10"/>
                    <count group_id="B10" value="2"/>
                    <count group_id="B11" value="5"/>
                    <count group_id="B12" value="1"/>
                    <count group_id="B13" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="5"/>
                    <measurement group_id="B9" value="10"/>
                    <measurement group_id="B10" value="2"/>
                    <measurement group_id="B11" value="5"/>
                    <measurement group_id="B12" value="1"/>
                    <measurement group_id="B13" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline serological cytomegalovirus positivity</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2"/>
                    <count group_id="B2" value="5"/>
                    <count group_id="B3" value="2"/>
                    <count group_id="B4" value="5"/>
                    <count group_id="B5" value="2"/>
                    <count group_id="B6" value="4"/>
                    <count group_id="B7" value="2"/>
                    <count group_id="B8" value="5"/>
                    <count group_id="B9" value="10"/>
                    <count group_id="B10" value="2"/>
                    <count group_id="B11" value="5"/>
                    <count group_id="B12" value="1"/>
                    <count group_id="B13" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Negative</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="3"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="5"/>
                    <measurement group_id="B9" value="5"/>
                    <measurement group_id="B10" value="1"/>
                    <measurement group_id="B11" value="4"/>
                    <measurement group_id="B12" value="1"/>
                    <measurement group_id="B13" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Positive</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="5"/>
                    <measurement group_id="B10" value="1"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="1"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline serological Epstein-Barr virus positivity</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2"/>
                    <count group_id="B2" value="5"/>
                    <count group_id="B3" value="2"/>
                    <count group_id="B4" value="5"/>
                    <count group_id="B5" value="2"/>
                    <count group_id="B6" value="4"/>
                    <count group_id="B7" value="2"/>
                    <count group_id="B8" value="5"/>
                    <count group_id="B9" value="10"/>
                    <count group_id="B10" value="2"/>
                    <count group_id="B11" value="5"/>
                    <count group_id="B12" value="1"/>
                    <count group_id="B13" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Negative</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="4"/>
                    <measurement group_id="B9" value="4"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="4"/>
                    <measurement group_id="B12" value="1"/>
                    <measurement group_id="B13" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Positive</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="6"/>
                    <measurement group_id="B10" value="2"/>
                    <measurement group_id="B11" value="1"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Autoantibody positivity - GAD65</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2"/>
                    <count group_id="B2" value="5"/>
                    <count group_id="B3" value="2"/>
                    <count group_id="B4" value="5"/>
                    <count group_id="B5" value="2"/>
                    <count group_id="B6" value="4"/>
                    <count group_id="B7" value="2"/>
                    <count group_id="B8" value="5"/>
                    <count group_id="B9" value="10"/>
                    <count group_id="B10" value="2"/>
                    <count group_id="B11" value="5"/>
                    <count group_id="B12" value="1"/>
                    <count group_id="B13" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Negative</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="2"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Positive</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="3"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="5"/>
                    <measurement group_id="B9" value="10"/>
                    <measurement group_id="B10" value="2"/>
                    <measurement group_id="B11" value="3"/>
                    <measurement group_id="B12" value="1"/>
                    <measurement group_id="B13" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</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="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Autoantibody positivity - IA-2</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2"/>
                    <count group_id="B2" value="5"/>
                    <count group_id="B3" value="2"/>
                    <count group_id="B4" value="5"/>
                    <count group_id="B5" value="2"/>
                    <count group_id="B6" value="4"/>
                    <count group_id="B7" value="2"/>
                    <count group_id="B8" value="5"/>
                    <count group_id="B9" value="10"/>
                    <count group_id="B10" value="2"/>
                    <count group_id="B11" value="5"/>
                    <count group_id="B12" value="1"/>
                    <count group_id="B13" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Negative</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="5"/>
                    <measurement group_id="B10" value="1"/>
                    <measurement group_id="B11" value="1"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Positive</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="3"/>
                    <measurement group_id="B10" value="1"/>
                    <measurement group_id="B11" value="4"/>
                    <measurement group_id="B12" value="1"/>
                    <measurement group_id="B13" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</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="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="2"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Autoantibody positivity - ZnT8</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2"/>
                    <count group_id="B2" value="5"/>
                    <count group_id="B3" value="2"/>
                    <count group_id="B4" value="5"/>
                    <count group_id="B5" value="2"/>
                    <count group_id="B6" value="4"/>
                    <count group_id="B7" value="2"/>
                    <count group_id="B8" value="5"/>
                    <count group_id="B9" value="10"/>
                    <count group_id="B10" value="2"/>
                    <count group_id="B11" value="5"/>
                    <count group_id="B12" value="1"/>
                    <count group_id="B13" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Negative</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="2"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Positive</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="3"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="3"/>
                    <measurement group_id="B9" value="5"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="3"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="3"/>
                    <measurement group_id="B10" value="2"/>
                    <measurement group_id="B11" value="2"/>
                    <measurement group_id="B12" value="1"/>
                    <measurement group_id="B13" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Autoantibody positivity - Insulin</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2"/>
                    <count group_id="B2" value="5"/>
                    <count group_id="B3" value="2"/>
                    <count group_id="B4" value="5"/>
                    <count group_id="B5" value="2"/>
                    <count group_id="B6" value="4"/>
                    <count group_id="B7" value="2"/>
                    <count group_id="B8" value="5"/>
                    <count group_id="B9" value="10"/>
                    <count group_id="B10" value="2"/>
                    <count group_id="B11" value="5"/>
                    <count group_id="B12" value="1"/>
                    <count group_id="B13" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Negative</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="5"/>
                    <measurement group_id="B10" value="1"/>
                    <measurement group_id="B11" value="3"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Positive</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="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="1"/>
                    <measurement group_id="B11" value="1"/>
                    <measurement group_id="B12" value="1"/>
                    <measurement group_id="B13" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</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="2"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="5"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="1"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Insulin required at baseline</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2"/>
                    <count group_id="B2" value="5"/>
                    <count group_id="B3" value="2"/>
                    <count group_id="B4" value="5"/>
                    <count group_id="B5" value="2"/>
                    <count group_id="B6" value="4"/>
                    <count group_id="B7" value="2"/>
                    <count group_id="B8" value="5"/>
                    <count group_id="B9" value="10"/>
                    <count group_id="B10" value="2"/>
                    <count group_id="B11" value="5"/>
                    <count group_id="B12" value="1"/>
                    <count group_id="B13" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="5"/>
                    <measurement group_id="B9" value="10"/>
                    <measurement group_id="B10" value="2"/>
                    <measurement group_id="B11" value="5"/>
                    <measurement group_id="B12" value="1"/>
                    <measurement group_id="B13" value="43"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</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="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline HbA1c</title>
          <description>Percentage of hemoglobin proteins in the blood that are glycated (i.e., the percentage of hemoglobin proteins that hold glucose).</description>
          <population>this assessment was not required for single dose patients, result not available</population>
          <units>percent</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="5"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="5"/>
                    <count group_id="B5" value="0"/>
                    <count group_id="B6" value="4"/>
                    <count group_id="B7" value="0"/>
                    <count group_id="B8" value="5"/>
                    <count group_id="B9" value="10"/>
                    <count group_id="B10" value="2"/>
                    <count group_id="B11" value="5"/>
                    <count group_id="B12" value="1"/>
                    <count group_id="B13" value="37"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B2" value="6.38" spread="0.56"/>
                    <measurement group_id="B4" value="7.00" spread="1.57"/>
                    <measurement group_id="B6" value="6.40" spread="0.51"/>
                    <measurement group_id="B8" value="6.28" spread="0.89"/>
                    <measurement group_id="B9" value="6.92" spread="1.42"/>
                    <measurement group_id="B10" value="7.35" spread="3.04"/>
                    <measurement group_id="B11" value="7.14" spread="2.43"/>
                    <measurement group_id="B12" value="8.40"/>
                    <measurement group_id="B13" value="6.86" spread="1.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Time from diagnosis to treatment</title>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2"/>
                    <count group_id="B2" value="5"/>
                    <count group_id="B3" value="2"/>
                    <count group_id="B4" value="5"/>
                    <count group_id="B5" value="2"/>
                    <count group_id="B6" value="4"/>
                    <count group_id="B7" value="2"/>
                    <count group_id="B8" value="5"/>
                    <count group_id="B9" value="10"/>
                    <count group_id="B10" value="2"/>
                    <count group_id="B11" value="5"/>
                    <count group_id="B12" value="1"/>
                    <count group_id="B13" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="84.5" spread="44.5"/>
                    <measurement group_id="B2" value="91.0" spread="38.2"/>
                    <measurement group_id="B3" value="45.5" spread="20.5"/>
                    <measurement group_id="B4" value="100" spread="42.2"/>
                    <measurement group_id="B5" value="146.0" spread="4.2"/>
                    <measurement group_id="B6" value="95.0" spread="21.3"/>
                    <measurement group_id="B7" value="113.0" spread="53.7"/>
                    <measurement group_id="B8" value="126.4" spread="19.4"/>
                    <measurement group_id="B9" value="101.0" spread="35.9"/>
                    <measurement group_id="B10" value="70.0" spread="15.6"/>
                    <measurement group_id="B11" value="122.6" spread="36.3"/>
                    <measurement group_id="B12" value="90.0"/>
                    <measurement group_id="B13" value="102.2" spread="36.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline IDAA1c</title>
          <description>IDAA1c or insulin dose adjusted HbA1c is a calculated unit. Formula:&#xD;
IDAA1c = HbA1c (%) + 4*total daily insulin dose (IU/kg)&#xD;
IDAA1c values below or equal to 9 generally represent partial disease remission.</description>
          <population>this assessment was not required for single dose patients, result not available</population>
          <units>units on a scale'</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="5"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="5"/>
                    <count group_id="B5" value="0"/>
                    <count group_id="B6" value="4"/>
                    <count group_id="B7" value="0"/>
                    <count group_id="B8" value="5"/>
                    <count group_id="B9" value="10"/>
                    <count group_id="B10" value="2"/>
                    <count group_id="B11" value="5"/>
                    <count group_id="B12" value="1"/>
                    <count group_id="B13" value="37"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B2" value="7.385" spread="1.303"/>
                    <measurement group_id="B4" value="8.248" spread="2.369"/>
                    <measurement group_id="B6" value="9.090" spread="1.093"/>
                    <measurement group_id="B8" value="8.392" spread="2.470"/>
                    <measurement group_id="B9" value="8.412" spread="1.725"/>
                    <measurement group_id="B10" value="8.530" spread="4.540"/>
                    <measurement group_id="B11" value="9.605" spread="2.583"/>
                    <measurement group_id="B12" value="10.640"/>
                    <measurement group_id="B13" value="8.55" spread="2.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Fasting C-peptide</title>
          <population>this assessment was not required for single dose patients, result not available</population>
          <units>nmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="5"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="5"/>
                    <count group_id="B5" value="0"/>
                    <count group_id="B6" value="4"/>
                    <count group_id="B7" value="0"/>
                    <count group_id="B8" value="5"/>
                    <count group_id="B9" value="10"/>
                    <count group_id="B10" value="2"/>
                    <count group_id="B11" value="5"/>
                    <count group_id="B12" value="1"/>
                    <count group_id="B13" value="37"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B2" value="0.27" spread="0.15"/>
                    <measurement group_id="B4" value="0.38" spread="0.19"/>
                    <measurement group_id="B6" value="0.33" spread="0.08"/>
                    <measurement group_id="B8" value="0.27" spread="0.14"/>
                    <measurement group_id="B9" value="0.18" spread="0.13"/>
                    <measurement group_id="B10" value="0.36" spread="0.22"/>
                    <measurement group_id="B11" value="0.25" spread="0.07"/>
                    <measurement group_id="B12" value="0.16"/>
                    <measurement group_id="B13" value="0.65" spread="0.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Peak stimulated C-peptide</title>
          <population>this assessment was not required for single dose patients, result not available</population>
          <units>nmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="5"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="5"/>
                    <count group_id="B5" value="0"/>
                    <count group_id="B6" value="4"/>
                    <count group_id="B7" value="0"/>
                    <count group_id="B8" value="5"/>
                    <count group_id="B9" value="10"/>
                    <count group_id="B10" value="2"/>
                    <count group_id="B11" value="5"/>
                    <count group_id="B12" value="1"/>
                    <count group_id="B13" value="37"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B2" value="0.92" spread="0.35"/>
                    <measurement group_id="B4" value="1.26" spread="1.12"/>
                    <measurement group_id="B6" value="0.97" spread="0.45"/>
                    <measurement group_id="B8" value="0.81" spread="0.09"/>
                    <measurement group_id="B9" value="0.71" spread="0.26"/>
                    <measurement group_id="B10" value="1.10" spread="0.11"/>
                    <measurement group_id="B11" value="0.76" spread="0.25"/>
                    <measurement group_id="B12" value="0.28"/>
                    <measurement group_id="B13" value="2.08" spread="1.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Mean 2H C-peptide AUC</title>
          <description>Mixed Meal Tolerance test (MMTT)-stimulated 2-hour C-peptide area under the curve (AUC) was defined as the mean area under the C-peptide level time curve over the 2-hour period divided by the duration after an MMTT.&#xD;
Mean 2h AUC is the AUC (expressed as nmol*min/L) divided by the number of minutes (120 min).</description>
          <population>this assessment was not required for single dose patients, result not available</population>
          <units>nmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="5"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="5"/>
                    <count group_id="B5" value="0"/>
                    <count group_id="B6" value="4"/>
                    <count group_id="B7" value="0"/>
                    <count group_id="B8" value="5"/>
                    <count group_id="B9" value="10"/>
                    <count group_id="B10" value="2"/>
                    <count group_id="B11" value="5"/>
                    <count group_id="B12" value="1"/>
                    <count group_id="B13" value="37"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B2" value="0.418" spread="0.257"/>
                    <measurement group_id="B4" value="0.500" spread="0.327"/>
                    <measurement group_id="B6" value="0.428" spread="0.134"/>
                    <measurement group_id="B8" value="0.512" spread="0.484"/>
                    <measurement group_id="B9" value="0.464" spread="0.255"/>
                    <measurement group_id="B10" value="0.396" spread="0.000"/>
                    <measurement group_id="B11" value="0.665" spread="0.160"/>
                    <measurement group_id="B12" value="0.000" spread="0.000"/>
                    <measurement group_id="B13" value="0.63" spread="0.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Total daily insulin use</title>
          <population>this assessment was not required for single dose patients, result not available</population>
          <units>IU/kg/d</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="5"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="5"/>
                    <count group_id="B5" value="0"/>
                    <count group_id="B6" value="4"/>
                    <count group_id="B7" value="0"/>
                    <count group_id="B8" value="5"/>
                    <count group_id="B9" value="10"/>
                    <count group_id="B10" value="2"/>
                    <count group_id="B11" value="5"/>
                    <count group_id="B12" value="1"/>
                    <count group_id="B13" value="37"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B2" value="0.23" spread="0.18"/>
                    <measurement group_id="B4" value="0.39" spread="0.20"/>
                    <measurement group_id="B6" value="0.67" spread="0.27"/>
                    <measurement group_id="B8" value="0.53" spread="0.46"/>
                    <measurement group_id="B9" value="0.37" spread="0.14"/>
                    <measurement group_id="B10" value="0.30" spread="0.37"/>
                    <measurement group_id="B11" value="0.51" spread="0.18"/>
                    <measurement group_id="B12" value="0.56"/>
                    <measurement group_id="B13" value="0.42" spread="0.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Incidence of Treatment-emergent Adverse Events (TEAE)</title>
        <description>Treatment-emergent adverse events assessed by the investigator, review of lab reports and information provided by the participant during site visits and/or participant diary with AG019 alone or with teplizumab</description>
        <time_frame>up to 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AG019 Cohort 1 - Low (Single) Dose/Adults</title>
            <description>AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 1 day (single dose)</description>
          </group>
          <group group_id="O2">
            <title>AG019 Cohort 1 - Low (Repeat) Dose/Adults</title>
            <description>AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 8 weeks (repeat dose)</description>
          </group>
          <group group_id="O3">
            <title>AG019 Cohort 2 - High (Single) Dose/Adults</title>
            <description>AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 1 day (single dose)</description>
          </group>
          <group group_id="O4">
            <title>AG019 Cohort 2 - High (Repeat) Dose/Adults</title>
            <description>AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose)</description>
          </group>
          <group group_id="O5">
            <title>AG019 Cohort 3 - Low (Single) Dose/Adolescents</title>
            <description>AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 1 day (single dose)</description>
          </group>
          <group group_id="O6">
            <title>AG019 Cohort 3 - Low (Repeat) Dose/Adolescents</title>
            <description>AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 8 weeks (repeat dose)</description>
          </group>
          <group group_id="O7">
            <title>AG019 Cohort 4 - High (Single) Dose/Adolescents</title>
            <description>AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 1 day (single dose)</description>
          </group>
          <group group_id="O8">
            <title>AG019 Cohort 4 - High (Repeat) Dose/Adolescents</title>
            <description>AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose)</description>
          </group>
          <group group_id="O9">
            <title>Combination Cohort 1 - Active AG019/Teplizumab - Adults</title>
            <description>Teplizumab: Daily IV infusions of Teplizumab during the first 12 days of AG019 treatment. Total cumulative dose is approximately 17mg (dose calculation based on body surface area).&#xD;
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose).</description>
          </group>
          <group group_id="O10">
            <title>Combination Cohort 1 - AG019-placebo/Teplizumab-placebo - Adults</title>
            <description>Placebo-AG019: Formulated identically to AG019 with the active ingredient removed.&#xD;
Placebo-Teplizumab: Formulated identically to teplizumab with the active ingredient removed.</description>
          </group>
          <group group_id="O11">
            <title>Combination Cohort 2 - Active AG019/Teplizumab - Adolescents</title>
            <description>Teplizumab: Daily IV infusions of Teplizumab during the first 12 days of AG019 treatment. Total cumulative dose is approximately 17mg (dose calculation based on body surface area).&#xD;
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose).</description>
          </group>
          <group group_id="O12">
            <title>Combination Cohort 2 - AG019-placebo/Teplizumab-placebo - Adolescents</title>
            <description>Placebo-AG019: Formulated identically to AG019 with the active ingredient removed.&#xD;
Placebo-Teplizumab: Formulated identically to teplizumab with the active ingredient removed.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Treatment-emergent Adverse Events (TEAE)</title>
          <description>Treatment-emergent adverse events assessed by the investigator, review of lab reports and information provided by the participant during site visits and/or participant diary with AG019 alone or with teplizumab</description>
          <units>Events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="5"/>
                <count group_id="O5" value="2"/>
                <count group_id="O6" value="4"/>
                <count group_id="O7" value="2"/>
                <count group_id="O8" value="5"/>
                <count group_id="O9" value="10"/>
                <count group_id="O10" value="2"/>
                <count group_id="O11" value="5"/>
                <count group_id="O12" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="19"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="28"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="19"/>
                    <measurement group_id="O9" value="91"/>
                    <measurement group_id="O10" value="25"/>
                    <measurement group_id="O11" value="22"/>
                    <measurement group_id="O12" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AG019 in Systemic Circulation</title>
        <description>The presence of live L. lactis bacteria in blood will be assessed by plating</description>
        <time_frame>Up to 3 months after initiation of the treatment</time_frame>
        <population>This assessment was not required for single dose patients, result not available</population>
        <group_list>
          <group group_id="O1">
            <title>AG019 Cohort 1 - Low (Repeat) Dose/Adults</title>
            <description>AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 8 weeks (repeat dose)</description>
          </group>
          <group group_id="O2">
            <title>AG019 Cohort 2 - High (Repeat) Dose/Adults</title>
            <description>AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose)</description>
          </group>
          <group group_id="O3">
            <title>AG019 Cohort 3 - Low (Repeat) Dose/Adolescents</title>
            <description>AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 8 weeks (repeat dose)</description>
          </group>
          <group group_id="O4">
            <title>AG019 Cohort 4 - High (Repeat) Dose/Adolescents</title>
            <description>AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose)</description>
          </group>
          <group group_id="O5">
            <title>Combination Cohort 1 - Active AG019/Teplizumab - Adults</title>
            <description>Teplizumab: Daily IV infusions of Teplizumab during the first 12 days of AG019 treatment. Total cumulative dose is approximately 17mg (dose calculation based on body surface area).&#xD;
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose).</description>
          </group>
          <group group_id="O6">
            <title>Combination Cohort 1 - AG019-placebo/Teplizumab-placebo - Adults</title>
            <description>Placebo-AG019: Formulated identically to AG019 with the active ingredient removed.&#xD;
Placebo-Teplizumab: Formulated identically to teplizumab with the active ingredient removed.</description>
          </group>
          <group group_id="O7">
            <title>Combination Cohort 2 - Active AG019/Teplizumab - Adolescents</title>
            <description>Teplizumab: Daily IV infusions of Teplizumab during the first 12 days of AG019 treatment. Total cumulative dose is approximately 17mg (dose calculation based on body surface area).&#xD;
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose).</description>
          </group>
          <group group_id="O8">
            <title>Combination Cohort 2 - AG019-placebo/Teplizumab-placebo - Adolescents</title>
            <description>Placebo-AG019: Formulated identically to AG019 with the active ingredient removed.&#xD;
Placebo-Teplizumab: Formulated identically to teplizumab with the active ingredient removed.</description>
          </group>
        </group_list>
        <measure>
          <title>AG019 in Systemic Circulation</title>
          <description>The presence of live L. lactis bacteria in blood will be assessed by plating</description>
          <population>This assessment was not required for single dose patients, result not available</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="5"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="5"/>
                <count group_id="O5" value="10"/>
                <count group_id="O6" value="2"/>
                <count group_id="O7" value="4"/>
                <count group_id="O8" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>L. Lactis-secreted hPINS or hIL-10 in Systemic Circulation</title>
        <description>The presence of L. lactis-secreted hPINS or hIL-10 in the blood will be assessed by ELISA (enzyme-linked immunosorbent assay)</description>
        <time_frame>Up to 3 months after initiation of the treatment</time_frame>
        <population>Indication for exposure of AG019 secreted hPINS or hIL-10 protein in plasma This assessment was not required for single dose patients, result not available</population>
        <group_list>
          <group group_id="O1">
            <title>AG019 Cohort 1 - Low (Repeat) Dose/Adults</title>
            <description>AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 8 weeks (repeat dose)</description>
          </group>
          <group group_id="O2">
            <title>AG019 Cohort 2 - High (Repeat) Dose/Adults</title>
            <description>AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose)</description>
          </group>
          <group group_id="O3">
            <title>AG019 Cohort 3 - Low (Repeat) Dose/Adolescents</title>
            <description>AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 8 weeks (repeat dose)</description>
          </group>
          <group group_id="O4">
            <title>AG019 Cohort 4 - High (Repeat) Dose/Adolescents</title>
            <description>AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose)</description>
          </group>
          <group group_id="O5">
            <title>Combination Cohort 1 - Active AG019/Teplizumab - Adults</title>
            <description>Teplizumab: Daily IV infusions of Teplizumab during the first 12 days of AG019 treatment. Total cumulative dose is approximately 17mg (dose calculation based on body surface area).&#xD;
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose).</description>
          </group>
          <group group_id="O6">
            <title>Combination Cohort 1 - AG019-placebo/Teplizumab-placebo - Adults</title>
            <description>Placebo-AG019: Formulated identically to AG019 with the active ingredient removed.&#xD;
Placebo-Teplizumab: Formulated identically to teplizumab with the active ingredient removed.</description>
          </group>
          <group group_id="O7">
            <title>Combination Cohort 2 - Active AG019/Teplizumab - Adolescents</title>
            <description>Teplizumab: Daily IV infusions of Teplizumab during the first 12 days of AG019 treatment. Total cumulative dose is approximately 17mg (dose calculation based on body surface area).&#xD;
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose).</description>
          </group>
          <group group_id="O8">
            <title>Combination Cohort 2 - AG019-placebo/Teplizumab-placebo - Adolescents</title>
            <description>Placebo-AG019: Formulated identically to AG019 with the active ingredient removed.&#xD;
Placebo-Teplizumab: Formulated identically to teplizumab with the active ingredient removed.</description>
          </group>
        </group_list>
        <measure>
          <title>L. Lactis-secreted hPINS or hIL-10 in Systemic Circulation</title>
          <description>The presence of L. lactis-secreted hPINS or hIL-10 in the blood will be assessed by ELISA (enzyme-linked immunosorbent assay)</description>
          <population>Indication for exposure of AG019 secreted hPINS or hIL-10 protein in plasma This assessment was not required for single dose patients, result not available</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="5"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="5"/>
                <count group_id="O5" value="10"/>
                <count group_id="O6" value="2"/>
                <count group_id="O7" value="4"/>
                <count group_id="O8" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AG019 in Feces</title>
        <description>The presence of L. lactis (live or dead) in feces will be assessed by Q-PCR (quantitative real-time polymerase chain reaction)</description>
        <time_frame>Up to 8 days after completion of the treatment</time_frame>
        <population>This assessment was not required for single dose patients, result not available</population>
        <group_list>
          <group group_id="O1">
            <title>AG019 Cohort 2 - High (Repeat) Dose/Adults</title>
            <description>AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose)</description>
          </group>
          <group group_id="O2">
            <title>AG019 Cohort 4 - High (Repeat) Dose/Adolescents</title>
            <description>AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose)</description>
          </group>
          <group group_id="O3">
            <title>Combination Cohort 1 - Active AG019/Teplizumab - Adults</title>
            <description>Teplizumab: Daily IV infusions of Teplizumab during the first 12 days of AG019 treatment. Total cumulative dose is approximately 17mg (dose calculation based on body surface area).&#xD;
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose).</description>
          </group>
          <group group_id="O4">
            <title>Combination Cohort 1 - AG019-placebo/Teplizumab-placebo - Adults</title>
            <description>Placebo-AG019: Formulated identically to AG019 with the active ingredient removed.&#xD;
Placebo-Teplizumab: Formulated identically to teplizumab with the active ingredient removed.</description>
          </group>
          <group group_id="O5">
            <title>Combination Cohort 2 - Active AG019/Teplizumab - Adolescents</title>
            <description>Teplizumab: Daily IV infusions of Teplizumab during the first 12 days of AG019 treatment. Total cumulative dose is approximately 17mg (dose calculation based on body surface area).&#xD;
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose).</description>
          </group>
          <group group_id="O6">
            <title>Combination Cohort 2 - AG019-placebo/Teplizumab-placebo - Adolescents</title>
            <description>Placebo-AG019: Formulated identically to AG019 with the active ingredient removed.&#xD;
Placebo-Teplizumab: Formulated identically to teplizumab with the active ingredient removed.</description>
          </group>
        </group_list>
        <measure>
          <title>AG019 in Feces</title>
          <description>The presence of L. lactis (live or dead) in feces will be assessed by Q-PCR (quantitative real-time polymerase chain reaction)</description>
          <population>This assessment was not required for single dose patients, result not available</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="5"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="2"/>
                <count group_id="O5" value="3"/>
                <count group_id="O6" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>participants with AG019 in feces</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>participants with no AG019 in feces</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>C-peptide Area Under the Concentration-time Curve (AUC) Calculated From a 2 Hour Mixed Meal Tolerance Test (MMTT) at 12 Months</title>
        <description>MMTT-stimulated 2-hour C-peptide AUC was defined as the mean area under the C-peptide level time curve over the 2-hour period divided by the duration after a mixed-meal tolerance test.</description>
        <time_frame>up to 12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AG019 Cohort 2 - High (Repeat) Dose/Adults</title>
            <description>AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose)</description>
          </group>
          <group group_id="O2">
            <title>AG019 Cohort 4 - High (Repeat) Dose/Adolescents</title>
            <description>AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose)</description>
          </group>
          <group group_id="O3">
            <title>Combination Cohort 1 - Active AG019/Teplizumab - Adults</title>
            <description>Teplizumab: Daily IV infusions of Teplizumab during the first 12 days of AG019 treatment. Total cumulative dose is approximately 17mg (dose calculation based on body surface area).&#xD;
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose).</description>
          </group>
          <group group_id="O4">
            <title>Combination Cohort 1 - AG019-placebo/Teplizumab-placebo - Adults</title>
            <description>Placebo-AG019: Formulated identically to AG019 with the active ingredient removed.&#xD;
Placebo-Teplizumab: Formulated identically to teplizumab with the active ingredient removed.</description>
          </group>
          <group group_id="O5">
            <title>Combination Cohort 2 - Active AG019/Teplizumab - Adolescents</title>
            <description>Teplizumab: Daily IV infusions of Teplizumab during the first 12 days of AG019 treatment. Total cumulative dose is approximately 17mg (dose calculation based on body surface area).&#xD;
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose).</description>
          </group>
          <group group_id="O6">
            <title>Combination Cohort 2 - AG019-placebo/Teplizumab-placebo - Adolescents</title>
            <description>Placebo-AG019: Formulated identically to AG019 with the active ingredient removed.&#xD;
Placebo-Teplizumab: Formulated identically to teplizumab with the active ingredient removed.</description>
          </group>
          <group group_id="O7">
            <title>AG019 Cohort 1 - Low (Repeat)-Dose/Adults</title>
            <description>AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 8 weeks (repeat dose)</description>
          </group>
          <group group_id="O8">
            <title>AG019 Cohort 3 - Low (Repeat) Dose/Adolescents</title>
            <description>AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 8 weeks (repeat dose)</description>
          </group>
        </group_list>
        <measure>
          <title>C-peptide Area Under the Concentration-time Curve (AUC) Calculated From a 2 Hour Mixed Meal Tolerance Test (MMTT) at 12 Months</title>
          <description>MMTT-stimulated 2-hour C-peptide AUC was defined as the mean area under the C-peptide level time curve over the 2-hour period divided by the duration after a mixed-meal tolerance test.</description>
          <units>nmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="2"/>
                <count group_id="O5" value="5"/>
                <count group_id="O6" value="1"/>
                <count group_id="O7" value="5"/>
                <count group_id="O8" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.89" spread="0.61"/>
                    <measurement group_id="O2" value="0.57" spread="0.13"/>
                    <measurement group_id="O3" value="0.48" spread="0.19"/>
                    <measurement group_id="O4" value="0.73" spread="0.01"/>
                    <measurement group_id="O5" value="0.57" spread="0.21"/>
                    <measurement group_id="O6" value="0.25" spread="0"/>
                    <measurement group_id="O7" value="0.62" spread="0.48"/>
                    <measurement group_id="O8" value="0.78" spread="0.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Incidence of Treatment Emergent Adverse Events up to 12 Months</title>
        <description>Incidence of all reported TEAE up to the 12-month follow-up visit. The TEAE are counted once within each patient on the preferred term level.</description>
        <time_frame>Up to 12 months from screening</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AG019 Cohort 1 - Low (Single) Dose/Adults</title>
            <description>AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 1 day (single dose)</description>
          </group>
          <group group_id="O2">
            <title>AG019 Cohort 1 - Low (Repeat) Dose/Adults</title>
            <description>AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 8 weeks (repeat dose)</description>
          </group>
          <group group_id="O3">
            <title>AG019 Cohort 2 - High (Single) Dose/Adults</title>
            <description>AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 1 day (single dose)</description>
          </group>
          <group group_id="O4">
            <title>AG019 Cohort 2 - High (Repeat) Dose/Adults</title>
            <description>AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose)</description>
          </group>
          <group group_id="O5">
            <title>AG019 Cohort 3 - Low (Single) Dose/Adolescents</title>
            <description>AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 1 day (single dose)</description>
          </group>
          <group group_id="O6">
            <title>AG019 Cohort 3 - Low (Repeat) Dose/Adolescents</title>
            <description>AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 8 weeks (repeat dose)</description>
          </group>
          <group group_id="O7">
            <title>AG019 Cohort 4 - High (Single) Dose/Adolescents</title>
            <description>AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 1 day (single dose)</description>
          </group>
          <group group_id="O8">
            <title>AG019 Cohort 4 - High (Repeat) Dose/Adolescents</title>
            <description>AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose)</description>
          </group>
          <group group_id="O9">
            <title>Combination Cohort 1 - Active AG019/Teplizumab - Adults</title>
            <description>Teplizumab: Daily IV infusions of Teplizumab during the first 12 days of AG019 treatment. Total cumulative dose is approximately 17mg (dose calculation based on body surface area).&#xD;
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks.</description>
          </group>
          <group group_id="O10">
            <title>Combination Cohort 1 - AG019-placebo/Teplizumab-placebo - Adults</title>
            <description>Placebo-AG019: Formulated identically to AG019 with the active ingredient removed.&#xD;
Placebo-Teplizumab: Formulated identically to teplizumab with the active ingredient removed.</description>
          </group>
          <group group_id="O11">
            <title>Combination Cohort 2 - Active AG019/Teplizumab - Adolescents</title>
            <description>Teplizumab: Daily IV infusions of Teplizumab during the first 12 days of AG019 treatment. Total cumulative dose is approximately 17mg (dose calculation based on body surface area).&#xD;
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks.</description>
          </group>
          <group group_id="O12">
            <title>Combination Cohort 2 - AG019-placebo/Teplizumab-placebo - Adolescents</title>
            <description>Placebo-AG019: Formulated identically to AG019 with the active ingredient removed.&#xD;
Placebo-Teplizumab: Formulated identically to teplizumab with the active ingredient removed.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Treatment Emergent Adverse Events up to 12 Months</title>
          <description>Incidence of all reported TEAE up to the 12-month follow-up visit. The TEAE are counted once within each patient on the preferred term level.</description>
          <units>events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="2"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="5"/>
                <count group_id="O5" value="2"/>
                <count group_id="O6" value="4"/>
                <count group_id="O7" value="2"/>
                <count group_id="O8" value="5"/>
                <count group_id="O9" value="10"/>
                <count group_id="O10" value="2"/>
                <count group_id="O11" value="5"/>
                <count group_id="O12" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="26"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="33"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="26"/>
                    <measurement group_id="O9" value="97"/>
                    <measurement group_id="O10" value="26"/>
                    <measurement group_id="O11" value="23"/>
                    <measurement group_id="O12" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected from signature of informed consent until completion of the study (or premature withdrawal), an average of 13 months (1 month of screening plus 12 months of study participation).</time_frame>
      <desc>All adverse events are listed, regardless of treatment emergence, severity, or relationship to AG019 or teplizumab. The results of the primary endpoint (incidence of TEAE up to 6 months) are outlined in the Endpoints section.</desc>
      <group_list>
        <group group_id="E1">
          <title>AG019 Cohort 1 - Low (Single) Dose/Adults</title>
          <description>AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 1 day (single dose)</description>
        </group>
        <group group_id="E2">
          <title>AG019 Cohort 1 - Low (Repeat) Dose/Adults</title>
          <description>AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 8 weeks (repeat dose)</description>
        </group>
        <group group_id="E3">
          <title>AG019 Cohort 2 - High (Single) Dose/Adults</title>
          <description>AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 1 day (single dose)</description>
        </group>
        <group group_id="E4">
          <title>AG019 Cohort 2 - High (Repeat) Dose/Adults</title>
          <description>AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose)</description>
        </group>
        <group group_id="E5">
          <title>AG019 Cohort 3 - Low (Single) Dose/Adolescents</title>
          <description>AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 1 day (single dose)</description>
        </group>
        <group group_id="E6">
          <title>AG019 Cohort 3 - Low (Repeat) Dose/Adolescents</title>
          <description>AG019 - Low Dose: Solid, orally administered capsule - 2 capsules per day for 8 weeks (repeat dose)</description>
        </group>
        <group group_id="E7">
          <title>AG019 Cohort 4 - High (Single) Dose/Adolescents</title>
          <description>AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 1 day (single dose)</description>
        </group>
        <group group_id="E8">
          <title>AG019 Cohort 4 - High (Repeat) Dose/Adolescents</title>
          <description>AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose)</description>
        </group>
        <group group_id="E9">
          <title>Combination Cohort 1 - Active AG019/Teplizumab - Adults</title>
          <description>Teplizumab: Daily IV infusions of Teplizumab during the first 12 days of AG019 treatment. Total cumulative dose is approximately 17mg (dose calculation based on body surface area).&#xD;
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose).</description>
        </group>
        <group group_id="E10">
          <title>Combination Cohort 1 - AG019-placebo/Teplizumab-placebo - Adults</title>
          <description>Placebo-AG019: Formulated identically to AG019 with the active ingredient removed.&#xD;
Placebo-Teplizumab: Formulated identically to teplizumab with the active ingredient removed.</description>
        </group>
        <group group_id="E11">
          <title>Combination Cohort 2 - Active AG019/Teplizumab - Adolescents</title>
          <description>Teplizumab: Daily IV infusions of Teplizumab during the first 12 days of AG019 treatment. Total cumulative dose is approximately 17mg (dose calculation based on body surface area).&#xD;
AG019 - High Dose: Solid, orally administered capsule - 6 capsules per day for 8 weeks (repeat dose).</description>
        </group>
        <group group_id="E12">
          <title>Combination Cohort 2 - AG019-placebo/Teplizumab-placebo - Adolescents</title>
          <description>Placebo-AG019: Formulated identically to AG019 with the active ingredient removed.&#xD;
Placebo-Teplizumab: Formulated identically to teplizumab with the active ingredient removed.</description>
        </group>
      </group_list>
      <serious_events>
        <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="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (21.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="5" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Eosinophilia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Erythropenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Iron deficiency anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" events="2" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" events="3" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E9" events="3" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="6" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Microcytic anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" events="3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="5" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Sinus bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Motion sickness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Tinnitus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Retinopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Abdominal tenderness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Chronic gastritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Coeliac disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" events="4" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="4" subjects_affected="4" subjects_at_risk="10"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Gingival bleeding</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Glossitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Lip dry</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="4" subjects_affected="4" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Tongue dry</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="3" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E9" events="12" subjects_affected="4" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="2" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Administration site pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Catheter site pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Catheter site pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Catheter site related reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E10" events="3" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Infusion site irritation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" events="2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Cytokine release syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Selective IgA immunodeficiency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Body tinea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hordeolum</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Infectious mononucleosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Medical device site infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="3" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Otitis externa</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Tooth abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="4" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Foot fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hand fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Joint Injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Muscle strain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Skin laceration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Thermal burn</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Tooth fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Wound</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Blood glucose decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Blood lactate dehydrogenase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Blood potassium increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Blood urea increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Blood uric acid increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Body Temperature decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>C-reactive protein increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Eosinophil count increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Epstein-Barr virus test positive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Glycosylated haemoglobin increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>International normalised ratio increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" events="4" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Liver function test abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="3" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="2" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Monocyte count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Platelet count increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Protein total increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Prothrombin time prolonged</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Red blood cell count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>haemoglobin increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="3" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E4" events="8" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Iron deficiency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Vitamin D deficiency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Growing pains</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Medial tibial stress syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Muscle twitching</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="5" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="2" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Systemic lupus erythematosus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dizziness postural</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="7" subjects_affected="5" subjects_at_risk="10"/>
                <counts group_id="E10" events="11" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E11" events="3" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Tension headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Attention deficit hyperactivity disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Panic attack</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Dysmenorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Scrotal irritation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Vulvovaginal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" events="2" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="2" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Nasal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="6" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Painful respiration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Tonsillar hypertrophy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="5" subjects_affected="5" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Rash papular</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Scab</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Pallor</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="1"/>
              </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>Confidentiality and consulting agreements restrict the dissemination of confidential information, but PIs are not restricted to act as a consultant for other companies.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Sven Blomme</name_or_title>
      <organization>Precigen Actobio T1D, LLC</organization>
      <phone>+3292771177</phone>
      <email>sblomme@actobio.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/NCT03751007
org study id: AG019-T1D-101
secondary id: 2017-002871-24
nct id: NCT03751007
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to assess the safety and tolerability of different doses of
      AG019 administered alone or in combination with teplizumab in participants with recent-onset
      type 1 diabetes (T1D).
This Phase 1b/2a, multi-center study will be conducted in participants with clinical
      recent-onset type 1 diabetes (T1D).

      The primary objective of this study is to assess the safety and tolerability of different
      doses of AG019 alone as well as AG019 in combination with teplizumab. The secondary
      objectives of this study are: to obtain pharmacodynamic (PD) data of AG019 alone as well as
      AG019 in combination with teplizumab; and to determine the potential presence of AG019 in
      systemic circulation (safety - systemic exposure) and the presence of L. lactis bacteria in
      fecal excretion (local exposure): Pharmacokinetic (PK) profile.

      This study consists of 2 phases:

      Phase 1b: this open-label part of the study will investigate the safety and tolerability of 2
      different doses of AG019 in 2 age groups (18-40 years of age and 12-17 years of age).

      Phase 2a: this randomized, double-blind part of the study will investigate the safety and
      tolerability of AG019, in combination with teplizumab, in 2 age groups (18-40 years of age
      and 12-17 years of age).
allocation: Randomized
intervention model: Sequential Assignment
intervention model description: The phase 1b part of the study will enroll 4 sequential AG019 cohorts of up to 6 participants, in ascending dose cohorts and descending age cohorts. All participants in these cohorts will be treated with AG019 in an open label fashion.
The phase 2a part of the study will evaluate 2 cohorts of participants administered AG019 and teplizumab. The first 2 participants will be treated with active treatment in an open label fashion. Participants 3-12 will be randomized (4:1) to receive active treatment or placebo in a double-blind fashion.
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: For the randomized participants in the combination cohorts, blinding will be accomplished by arranging for AG019 and placebo components as well as teplizumab and placebo components to have identical packaging.
measure: Incidence of Treatment-emergent Adverse Events (TEAE)
time frame: up to 6 months
description: Treatment-emergent adverse events assessed by the investigator, review of lab reports and information provided by the participant during site visits and/or participant diary with AG019 alone or with teplizumab
measure: AG019 in Systemic Circulation
time frame: Up to 3 months after initiation of the treatment
description: The presence of live L. lactis bacteria in blood will be assessed by plating
measure: L. Lactis-secreted hPINS or hIL-10 in Systemic Circulation
time frame: Up to 3 months after initiation of the treatment
description: The presence of L. lactis-secreted hPINS or hIL-10 in the blood will be assessed by ELISA (enzyme-linked immunosorbent assay)
measure: AG019 in Feces
time frame: Up to 8 days after completion of the treatment
description: The presence of L. lactis (live or dead) in feces will be assessed by Q-PCR (quantitative real-time polymerase chain reaction)
measure: C-peptide Area Under the Concentration-time Curve (AUC) Calculated From a 2 Hour Mixed Meal Tolerance Test (MMTT) at 12 Months
time frame: up to 12 months
description: MMTT-stimulated 2-hour C-peptide AUC was defined as the mean area under the C-peptide level time curve over the 2-hour period divided by the duration after a mixed-meal tolerance test.
measure: Incidence of Treatment Emergent Adverse Events up to 12 Months
time frame: Up to 12 months from screening
description: Incidence of all reported TEAE up to the 12-month follow-up visit. The TEAE are counted once within each patient on the preferred term level.
arm group label: AG019 Cohort 1 - Low Dose/Adults
arm group type: Experimental
arm group label: AG019 Cohort 2 - High Dose/Adults
arm group type: Experimental
arm group label: AG019 Cohort 3 - Low Dose/Adolescents
arm group type: Experimental
arm group label: AG019 Cohort 4 - High Dose/Adolescents
arm group type: Experimental
arm group label: Combination Cohort 1 - Adults
arm group type: Experimental
arm group label: Combination Cohort 2 - Adolescents
arm group type: Experimental
intervention type: Biological
intervention name: AG019 - Low Dose
description: Solid, orally administered capsule - 2 capsules per day for 1 day (single dose) or 8 weeks (repeat dose)
arm group label: AG019 Cohort 1 - Low Dose/Adults
arm group label: AG019 Cohort 3 - Low Dose/Adolescents
intervention type: Drug
intervention name: Teplizumab
description: Daily IV infusions of Teplizumab during the first 12 days of AG019 treatment. Total cumulative dose is approximately 17mg (dose calculation based on body surface area).
arm group label: Combination Cohort 1 - Adults
arm group label: Combination Cohort 2 - Adolescents
intervention type: Drug
intervention name: Placebo-AG019
description: Formulated identically to AG019 with the active ingredient removed.
arm group label: Combination Cohort 1 - Adults
arm group label: Combination Cohort 2 - Adolescents
intervention type: Drug
intervention name: Placebo-Teplizumab
description: Formulated identically to teplizumab with the active ingredient removed.
arm group label: Combination Cohort 1 - Adults
arm group label: Combination Cohort 2 - Adolescents
intervention type: Biological
intervention name: AG019 - High Dose
description: Solid, orally administered capsule - 6 capsules per day for 1 day (single dose) or 8 weeks
arm group label: AG019 Cohort 2 - High Dose/Adults
arm group label: AG019 Cohort 4 - High Dose/Adolescents
intervention type: Biological
intervention name: AG019 - High Dose
description: Solid, orally administered capsule - 6 capsules per day for 8 weeks.
arm group label: Combination Cohort 1 - Adults
arm group label: Combination Cohort 2 - Adolescents
criteria: 
gender: All
minimum age: 12 Years
maximum age: 40 Years
healthy volunteers: No
last name: Chantal Mathieu, MD
role: Principal Investigator
affiliation: University Hospital of Leuven, Clinical and Experimental Endocrinology
last name: Kevan Herold, MD
role: Principal Investigator
affiliation: Yale Center for Clinical Investigation; Yale University
facility: 
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country: Belgium
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 