<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/NCT02255435</url>
  </required_header>
  <id_info>
    <org_study_id>RTA 408-C-1402</org_study_id>
    <nct_id>NCT02255435</nct_id>
  </id_info>
  <brief_title>RTA 408 Capsules in Patients With Friedreich's Ataxia - MOXIe</brief_title>
  <official_title>A Phase 2 Study of the Safety, Efficacy, and Pharmacodynamics of RTA 408 in the Treatment of Friedreich's Ataxia (MOXIe)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Reata Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AbbVie</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Friedreich's Ataxia Research Alliance</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Reata Pharmaceuticals, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Friedreich's ataxia is an autosomal recessive cerebellar ataxia caused by triplet-repeat&#xD;
      expansions. The causative mutation is a trinucleotide (GAA) repeat expansion in the first&#xD;
      intron of the frataxin gene, leading to impaired transcription of frataxin. The pathological&#xD;
      consequences of frataxin deficiency include a severe disruption of iron-sulfur cluster&#xD;
      biosynthesis, mitochondrial iron overload coupled to cellular iron dysregulation, and an&#xD;
      increased sensitivity to oxidative stress.&#xD;
&#xD;
      A hallmark of Friedreich's ataxia is impairment of antioxidative defense mechanisms, which&#xD;
      play a major role in disease progression. Studies have demonstrated that nuclear factor&#xD;
      erythroid-derived 2-related factor 2 (Nrf2) signaling is grossly impaired in patients with&#xD;
      Friedreich's ataxia. Therefore, the ability of omaveloxolone (RTA 408) to activate Nrf2 and&#xD;
      induce antioxidant target genes is hypothesized to be therapeutic in patients with&#xD;
      Friedreich's ataxia.&#xD;
&#xD;
      This 2-part study will evaluate the efficacy, safety, and pharmacodynamics of omaveloxolone&#xD;
      (RTA 408) in the treatment of patients with Friedreich's ataxia.&#xD;
&#xD;
      Part 1: The first part of this study will be a randomized, placebo-controlled, double-blind,&#xD;
      dose-escalation study to evaluate the safety of omaveloxolone (RTA 408) at various doses in&#xD;
      patients with Friedreich's ataxia.&#xD;
&#xD;
      Part 2: The second part of this study is a randomized, placebo-controlled, double-blind,&#xD;
      parallel-group study to evaluate the safety and efficacy of omaveloxolone (RTA 408) 150 mg in&#xD;
      patients with Friedreich's ataxia. Patients enrolled in Part 2 will be randomized 1:1 to&#xD;
      receive omaveloxolone (RTA 408) 150 mg or placebo.&#xD;
&#xD;
      Extension: The extension will assess long-term safety and tolerability of omaveloxolone (RTA&#xD;
      408) in qualified patients with Friedreich's ataxia following completion of Part 1 or Part 2.&#xD;
      Patients will not be unblinded to study treatment in Part 1 or Part 2 upon entering the&#xD;
      extension study. Patients will receive open-label omaveloxolone (RTA 408) at 150 mg once&#xD;
      daily.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Actual">October 31, 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Peak Work (in Watts/kg) During Exercise Testing at Week 12 in Part 1</measure>
    <time_frame>Baseline through 12 weeks after participant receives the first dose in Part 1.</time_frame>
    <description>Peak work attained during maximal exercise testing. Cycle ergometry using a recumbent stationary bicycle was used, and workload was increased incrementally. Peak work is defined as the workload at which patients reach maximal volition (defined as an inability to continue to exercise due to exhaustion).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the Modified Friedreich's Ataxia Rating Scale (mFARS) at Week 48 in Part 2</measure>
    <time_frame>48 weeks after participant receives the first dose in Part 2</time_frame>
    <description>The mFARS includes 4 of the 5 sections of the Friedreich's Ataxia Rating Scale (FARS): bulbar (score 0 to 11), upper limb coordination (score 0 to 36), lower limb coordination (score 0 to 16), and upright stability (score 0 to 36). The minimum score is 0 and the maximum score is 99. A lower score indicates better neurological function.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the Modified Friedreich's Ataxia Rating Scale (mFARS) at Week 12 in Part 1</measure>
    <time_frame>12 weeks after participant receives the first dose in Part 1</time_frame>
    <description>The mFARS includes 4 of the 5 sections of the Friedreich's Ataxia Rating Scale (FARS): bulbar (score 0 to 11), upper limb coordination (score 0 to 36), lower limb coordination (score 0 to 16), and upright stability (score 0 to 36). The minimum score is 0 and the maximum score is 99. A lower score indicates better neurological function.</description>
  </secondary_outcome>
  <number_of_arms>10</number_of_arms>
  <enrollment type="Actual">172</enrollment>
  <condition>Friedreich Ataxia</condition>
  <arm_group>
    <arm_group_label>Part 1 Omaveloxolone Capsules 2.5 and 5 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>omaveloxolone (RTA 408) Capsules, 2.5 mg administered orally one daily for 2 weeks, then 5 mg taken orally once daily for 10 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 1 Omaveloxolone Capsules 10 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>omaveloxolone (RTA 408) Capsules, 10 mg administered orally once daily for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 1 Omaveloxolone Capsules 20 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Omaveloxolone (RTA 408) Capsules, 20 mg administered orally once daily for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 1 Omaveloxolone Capsules 40 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Omaveloxolone (RTA 408) Capsules, 40 mg administered orally once daily for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 1 Omaveloxolone Capsules 80 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Omaveloxolone (RTA 408) Capsules, 80 mg administered orally once daily for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 1 Omaveloxolone Capsules 160 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Omaveloxolone (RTA 408) Capsules, 160 mg administered orally once daily for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 1 Omaveloxolone Capsules 300 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Omaveloxolone (RTA 408) Capsules, 300 mg administered orally once daily for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 1 Placebo Capsules</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo capsules administered orally once daily for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2 Placebo Capsules</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo capsules administered orally once daily for 48 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2 Omaveloxolone Capsules 150 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Omaveloxolone (RTA 408) Capsules, 150 mg administered orally once daily for 48 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Omaveloxolone Capsules, 2.5 mg</intervention_name>
    <arm_group_label>Part 1 Omaveloxolone Capsules 2.5 and 5 mg</arm_group_label>
    <other_name>RTA 408 Capsules 2.5 mg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Omaveloxolone Capsules, 5 mg</intervention_name>
    <arm_group_label>Part 1 Omaveloxolone Capsules 2.5 and 5 mg</arm_group_label>
    <other_name>RTA 408 capsules, 5 mg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Omaveloxolone Capsules, 10 mg</intervention_name>
    <arm_group_label>Part 1 Omaveloxolone Capsules 10 mg</arm_group_label>
    <other_name>RTA 408 capsules, 10 mg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Part 1 Placebo Capsules</arm_group_label>
    <arm_group_label>Part 2 Placebo Capsules</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Omaveloxolone Capsules, 20 mg</intervention_name>
    <arm_group_label>Part 1 Omaveloxolone Capsules 20 mg</arm_group_label>
    <other_name>RTA 408 capsules, 20 mg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Omaveloxolone Capsules, 40 mg</intervention_name>
    <arm_group_label>Part 1 Omaveloxolone Capsules 40 mg</arm_group_label>
    <other_name>RTA 408 capsules, 40 mg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Omaveloxolone Capsules, 80 mg</intervention_name>
    <arm_group_label>Part 1 Omaveloxolone Capsules 80 mg</arm_group_label>
    <other_name>RTA 408 capsules, 80 mg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Omaveloxolone Capsules, 160 mg</intervention_name>
    <arm_group_label>Part 1 Omaveloxolone Capsules 160 mg</arm_group_label>
    <other_name>RTA 408 capsules, 160 mg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Omaveloxolone Capsules, 300 mg</intervention_name>
    <arm_group_label>Part 1 Omaveloxolone Capsules 300 mg</arm_group_label>
    <other_name>RTA 408 capsules, 300 mg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Omaveloxolone Capsules, 150 mg</intervention_name>
    <arm_group_label>Part 2 Omaveloxolone Capsules 150 mg</arm_group_label>
    <other_name>RTA 408 capsules, 150 mg</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Have genetically confirmed Friedreich's ataxia&#xD;
&#xD;
          2. Have a modified FARS score ≥20 and ≤80&#xD;
&#xD;
          3. Be male or female and ≥16 years of age and ≤40 years of age&#xD;
&#xD;
          4. Have no changes to exercise regimen within 30 days prior to Study Day 1 and be willing&#xD;
             to remain on the same exercise regimen during the 16-week study period&#xD;
&#xD;
          5. Have the ability to complete maximal exercise testing&#xD;
&#xD;
          6. Be able to swallow capsules&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Have uncontrolled diabetes (HbA1c &gt;11.0%)&#xD;
&#xD;
          2. Have B-type natriuretic peptide value &gt;200 pg/mL&#xD;
&#xD;
          3. Have a history of clinically significant left-sided heart disease and/or clinically&#xD;
             significant cardiac disease&#xD;
&#xD;
          4. Have known active fungal, bacterial, and/or viral infection, including human&#xD;
             immunodeficiency virus or hepatitis virus (B or C)&#xD;
&#xD;
          5. Have known or suspected active drug or alcohol abuse&#xD;
&#xD;
          6. Have clinically significant abnormalities of clinical hematology or biochemistry,&#xD;
             including but not limited to elevations greater than 1.5 times the upper limit of&#xD;
             normal of aspartate aminotransferase, or alanine aminotransferase&#xD;
&#xD;
          7. Have any abnormal laboratory test value or serious pre-existing medical condition&#xD;
             that, in the opinion of the investigator, would put the patient at risk by study&#xD;
             enrollment&#xD;
&#xD;
          8. Have taken any of the following drugs within 7 days prior to Study Day 1 or plan to&#xD;
             take any of these drugs during the time of study participation:&#xD;
&#xD;
               1. Sensitive substrates for cytochrome P450 2C8 or 3A4 (e.g., repaglinide,&#xD;
                  midazolam, sildenafil)&#xD;
&#xD;
               2. Moderate or strong inhibitors or inducers of cytochrome P450 3A4 (e.g.,&#xD;
                  carbamazepine, phenytoin, ciprofloxacin, grapefruit juice)&#xD;
&#xD;
               3. Substrates for p-glycoprotein transporter (e.g., ambrisentan, digoxin)&#xD;
&#xD;
          9. Have participated in any other interventional clinical study within 30 days prior to&#xD;
             Study Day 1&#xD;
&#xD;
         10. Have a cognitive impairment that may preclude ability to comply with study procedures&#xD;
&#xD;
         11. Prior participation in a trial with omaveloxolone (RTA 408)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>UCLA</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florida - Neurology</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>USF Ataxia Research Center</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University Hospital - Neurology</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30329</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Iowa Stead Family Children's Hospital</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio State University - Neurology</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43221</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Murdoch Childrens Research Institute</name>
      <address>
        <city>Parkville</city>
        <state>Victoria</state>
        <zip>3052</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University Innsbruck</name>
      <address>
        <city>Innsbruck</city>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurological Institute Carlo Besta</name>
      <address>
        <city>Milan</city>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University College of London</name>
      <address>
        <city>London</city>
        <zip>WC1E 6BT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Italy</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Brazil</country>
  </removed_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>September 30, 2014</study_first_submitted>
  <study_first_submitted_qc>September 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <results_first_submitted>September 30, 2022</results_first_submitted>
  <results_first_submitted_qc>November 4, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">November 29, 2022</results_first_posted>
  <disposition_first_submitted>October 1, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>October 1, 2020</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">October 12, 2020</disposition_first_posted>
  <last_update_submitted>December 2, 2022</last_update_submitted>
  <last_update_submitted_qc>December 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>RTA 408</keyword>
  <keyword>RTA 408 Capsules</keyword>
  <keyword>Oxidative Stress</keyword>
  <keyword>Mitochondrial dysfunction</keyword>
  <keyword>omaveloxolone</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ataxia</mesh_term>
    <mesh_term>Cerebellar Ataxia</mesh_term>
    <mesh_term>Friedreich Ataxia</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol: Main 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 21, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/35/NCT02255435/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol: United Kingdom 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 21, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/35/NCT02255435/Prot_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan: Part 1</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 15, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/35/NCT02255435/SAP_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan: Part 2</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>September 18, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/35/NCT02255435/SAP_003.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan: Part 2 Addendum</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>October 9, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/35/NCT02255435/SAP_004.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>MOXIe Part 1 and Part 2 were conducted under the same protocol. Participants enrolled in Part 1 were not allowed to enroll in Part 2. Patients with pes cavus were not to comprise more than 20% of all patients enrolled in Part 2.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Part 1 Omaveloxolone Capsules 2.5 and 5 mg</title>
          <description>Omaveloxolone (RTA 408) Capsules, 2.5 mg administered orally one daily for 2 weeks, then 5 mg administered orally once daily for 10 weeks&#xD;
Omaveloxolone Capsules, 2.5 mg&#xD;
Omaveloxolone Capsules, 5 mg</description>
        </group>
        <group group_id="P2">
          <title>Part 1 Omaveloxolone Capsules 10 mg</title>
          <description>Omaveloxolone (RTA 408) Capsules, 10 mg administered orally once daily for 12 weeks&#xD;
Omaveloxolone Capsules, 10 mg</description>
        </group>
        <group group_id="P3">
          <title>Part 1 Omaveloxolone Capsules 20 mg</title>
          <description>Omaveloxolone (RTA 408) Capsules, 20 mg administered orally once daily for 12 weeks&#xD;
Omaveloxolone Capsules, 20 mg</description>
        </group>
        <group group_id="P4">
          <title>Part 1 Omaveloxolone Capsules 40 mg</title>
          <description>Omaveloxolone (RTA 408) Capsules, 40 mg administered orally once daily for 12 weeks&#xD;
Omaveloxolone Capsules, 40 mg</description>
        </group>
        <group group_id="P5">
          <title>Part 1 Omaveloxolone Capsules 80 mg</title>
          <description>Omaveloxolone (RTA 408) Capsules, 80 mg administered orally once daily for 12 weeks&#xD;
Omaveloxolone Capsules, 80 mg</description>
        </group>
        <group group_id="P6">
          <title>Part 1 Omaveloxolone Capsules 160 mg</title>
          <description>Omaveloxolone (RTA 408) Capsules, 160 mg administered orally once daily for 12 weeks&#xD;
Omaveloxolone Capsules, 160 mg</description>
        </group>
        <group group_id="P7">
          <title>Part 1 Omaveloxolone Capsules 300 mg</title>
          <description>Omaveloxolone (RTA 408) Capsules, 300 mg administered orally once daily for 12 weeks&#xD;
Omaveloxolone Capsules, 300 mg</description>
        </group>
        <group group_id="P8">
          <title>Part 1 Placebo Capsules</title>
          <description>Placebo capsules administered orally once daily for 12 weeks&#xD;
Placebo</description>
        </group>
        <group group_id="P9">
          <title>Part 2 Placebo Capsules</title>
          <description>Placebo capsules administered orally once daily for 48 weeks&#xD;
Placebo</description>
        </group>
        <group group_id="P10">
          <title>Part 2 Omaveloxolone Capsules 150 mg</title>
          <description>Omaveloxolone (RTA 408) Capsules, 150 mg administered orally once daily for 48 weeks&#xD;
Omaveloxolone Capsules, 150 mg</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="12"/>
                <participants group_id="P7" count="10"/>
                <participants group_id="P8" count="17"/>
                <participants group_id="P9" count="52"/>
                <participants group_id="P10" count="51"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Number of Participants With Pes Cavus</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="8"/>
                <participants group_id="P7" count="3"/>
                <participants group_id="P8" count="10"/>
                <participants group_id="P9" count="10"/>
                <participants group_id="P10" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="12"/>
                <participants group_id="P7" count="10"/>
                <participants group_id="P8" count="16"/>
                <participants group_id="P9" count="51"/>
                <participants group_id="P10" count="45"/>
              </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="0"/>
                <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="1"/>
                <participants group_id="P10" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Patient's Limited Time Availability</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="0"/>
                <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_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</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="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Administrative reasons</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="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All randomized patients, whether or not they received study drug</population>
      <group_list>
        <group group_id="B1">
          <title>Part 1 Omaveloxolone Capsules 2.5 and 5 mg</title>
          <description>Omaveloxolone (RTA 408) Capsules, 2.5 mg administered orally one daily for 2 weeks, then 5 mg administered orally once daily for 10 weeks&#xD;
Omaveloxolone Capsules, 2.5 mg&#xD;
Omaveloxolone Capsules, 5 mg</description>
        </group>
        <group group_id="B2">
          <title>Part 1 Omaveloxolone Capsules 10 mg</title>
          <description>Omaveloxolone (RTA 408) Capsules, 10 mg administered orally once daily for 12 weeks&#xD;
Omaveloxolone Capsules, 10 mg</description>
        </group>
        <group group_id="B3">
          <title>Part 1 Omaveloxolone Capsules 20 mg</title>
          <description>Omaveloxolone (RTA 408) Capsules, 20 mg administered orally once daily for 12 weeks&#xD;
Omaveloxolone Capsules, 20 mg</description>
        </group>
        <group group_id="B4">
          <title>Part 1 Omaveloxolone Capsules 40 mg</title>
          <description>Omaveloxolone (RTA 408) Capsules, 40 mg administered orally once daily for 12 weeks&#xD;
Omaveloxolone Capsules, 40 mg</description>
        </group>
        <group group_id="B5">
          <title>Part 1 Omaveloxolone Capsules 80 mg</title>
          <description>Omaveloxolone (RTA 408) Capsules, 80 mg administered orally once daily for 12 weeks&#xD;
Omaveloxolone Capsules, 80 mg</description>
        </group>
        <group group_id="B6">
          <title>Part 1 Omaveloxolone Capsules 160 mg</title>
          <description>Omaveloxolone (RTA 408) Capsules, 160 mg administered orally once daily for 12 weeks&#xD;
Omaveloxolone Capsules, 160 mg</description>
        </group>
        <group group_id="B7">
          <title>Part 1 Omaveloxolone Capsules 300 mg</title>
          <description>Omaveloxolone (RTA 408) Capsules, 300 mg administered orally once daily for 12 weeks&#xD;
Omaveloxolone Capsules, 300 mg</description>
        </group>
        <group group_id="B8">
          <title>Part 1 Placebo Capsules</title>
          <description>Placebo capsules administered orally once daily for 12 weeks&#xD;
Placebo</description>
        </group>
        <group group_id="B9">
          <title>Part 2 Placebo Capsules</title>
          <description>Placebo capsules administered orally once daily for 48 weeks&#xD;
Placebo</description>
        </group>
        <group group_id="B10">
          <title>Part 2 Omaveloxolone Capsules 150 mg</title>
          <description>Omaveloxolone (RTA 408) Capsules, 150 mg administered orally once daily for 48 weeks&#xD;
Omaveloxolone Capsules, 150 mg</description>
        </group>
        <group group_id="B11">
          <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="6"/>
            <count group_id="B2" value="6"/>
            <count group_id="B3" value="6"/>
            <count group_id="B4" value="6"/>
            <count group_id="B5" value="6"/>
            <count group_id="B6" value="12"/>
            <count group_id="B7" value="10"/>
            <count group_id="B8" value="17"/>
            <count group_id="B9" value="52"/>
            <count group_id="B10" value="51"/>
            <count group_id="B11" value="172"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25.8" spread="5.98"/>
                    <measurement group_id="B2" value="25.5" spread="7.4"/>
                    <measurement group_id="B3" value="28.3" spread="6.8"/>
                    <measurement group_id="B4" value="27.7" spread="7.53"/>
                    <measurement group_id="B5" value="24.3" spread="4.8"/>
                    <measurement group_id="B6" value="25.3" spread="6.51"/>
                    <measurement group_id="B7" value="25.6" spread="7.24"/>
                    <measurement group_id="B8" value="24.4" spread="6.74"/>
                    <measurement group_id="B9" value="24.1" spread="7.85"/>
                    <measurement group_id="B10" value="23.4" spread="6.08"/>
                    <measurement group_id="B11" value="24.5" spread="6.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="5"/>
                    <measurement group_id="B7" value="5"/>
                    <measurement group_id="B8" value="10"/>
                    <measurement group_id="B9" value="17"/>
                    <measurement group_id="B10" value="31"/>
                    <measurement group_id="B11" value="85"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="7"/>
                    <measurement group_id="B7" value="5"/>
                    <measurement group_id="B8" value="7"/>
                    <measurement group_id="B9" value="35"/>
                    <measurement group_id="B10" value="20"/>
                    <measurement group_id="B11" value="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <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="1"/>
                    <measurement group_id="B9" value="3"/>
                    <measurement group_id="B10" value="2"/>
                    <measurement group_id="B11" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="12"/>
                    <measurement group_id="B7" value="10"/>
                    <measurement group_id="B8" value="16"/>
                    <measurement group_id="B9" value="49"/>
                    <measurement group_id="B10" value="49"/>
                    <measurement group_id="B11" value="165"/>
                  </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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="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_list>
                </category>
                <category>
                  <title>Asian</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_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</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_list>
                </category>
                <category>
                  <title>Black or African American</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_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="11"/>
                    <measurement group_id="B7" value="10"/>
                    <measurement group_id="B8" value="16"/>
                    <measurement group_id="B9" value="50"/>
                    <measurement group_id="B10" value="50"/>
                    <measurement group_id="B11" value="167"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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_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="1"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="2"/>
                    <measurement group_id="B10" value="1"/>
                    <measurement group_id="B11" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Austria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="3"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="6"/>
                    <measurement group_id="B10" value="3"/>
                    <measurement group_id="B11" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="8"/>
                    <measurement group_id="B7" value="7"/>
                    <measurement group_id="B8" value="16"/>
                    <measurement group_id="B9" value="35"/>
                    <measurement group_id="B10" value="36"/>
                    <measurement group_id="B11" value="131"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement 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="3"/>
                    <measurement group_id="B10" value="5"/>
                    <measurement group_id="B11" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Italy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement 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="5"/>
                    <measurement group_id="B10" value="2"/>
                    <measurement group_id="B11" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Australia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="3"/>
                    <measurement group_id="B10" value="5"/>
                    <measurement group_id="B11" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Peak Work</title>
          <description>Peak work attained during maximal exercise testing. Cycle ergometry using a recumbent stationary bicycle was used, and workload was increased incrementally. Peak work is defined as the workload at which patients reach maximal volition (defined as an inability to continue to exercise due to exhaustion).</description>
          <units>W/kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.2" spread="0.696"/>
                    <measurement group_id="B2" value="0.78" spread="0.677"/>
                    <measurement group_id="B3" value="1.25" spread="0.838"/>
                    <measurement group_id="B4" value="0.72" spread="0.565"/>
                    <measurement group_id="B5" value="1.6" spread="0.556"/>
                    <measurement group_id="B6" value="1.18" spread="0.646"/>
                    <measurement group_id="B7" value="0.88" spread="0.521"/>
                    <measurement group_id="B8" value="0.99" spread="0.637"/>
                    <measurement group_id="B9" value="1.23" spread="0.622"/>
                    <measurement group_id="B10" value="1.09" spread="0.576"/>
                    <measurement group_id="B11" value="1.12" spread="0.621"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Peak Work (in Watts/kg) During Exercise Testing at Week 12 in Part 1</title>
        <description>Peak work attained during maximal exercise testing. Cycle ergometry using a recumbent stationary bicycle was used, and workload was increased incrementally. Peak work is defined as the workload at which patients reach maximal volition (defined as an inability to continue to exercise due to exhaustion).</description>
        <time_frame>Baseline through 12 weeks after participant receives the first dose in Part 1.</time_frame>
        <population>All randomized patients in Part 1, whether or not they received study drug</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1 Omaveloxolone Capsules 2.5 and 5 mg</title>
            <description>Omaveloxolone (RTA 408) Capsules, 2.5 mg administered orally one daily for 2 weeks, then 5 mg administered orally once daily for 10 weeks&#xD;
Omaveloxolone Capsules, 2.5 mg&#xD;
Omaveloxolone Capsules, 5 mg</description>
          </group>
          <group group_id="O2">
            <title>Part 1 Omaveloxolone Capsules 10 mg</title>
            <description>Omaveloxolone (RTA 408) Capsules, 10 mg administered orally once daily for 12 weeks&#xD;
Omaveloxolone Capsules, 10 mg</description>
          </group>
          <group group_id="O3">
            <title>Part 1 Omaveloxolone Capsules 20 mg</title>
            <description>Omaveloxolone (RTA 408) Capsules, 20 mg administered orally once daily for 12 weeks&#xD;
Omaveloxolone Capsules, 20 mg</description>
          </group>
          <group group_id="O4">
            <title>Part 1 Omaveloxolone Capsules 40 mg</title>
            <description>Omaveloxolone (RTA 408) Capsules, 40 mg administered orally once daily for 12 weeks&#xD;
Omaveloxolone Capsules, 40 mg</description>
          </group>
          <group group_id="O5">
            <title>Part 1 Omaveloxolone Capsules 80 mg</title>
            <description>Omaveloxolone (RTA 408) Capsules, 80 mg administered orally once daily for 12 weeks&#xD;
Omaveloxolone Capsules, 80 mg</description>
          </group>
          <group group_id="O6">
            <title>Part 1 Omaveloxolone Capsules 160 mg</title>
            <description>Omaveloxolone (RTA 408) Capsules, 160 mg administered orally once daily for 12 weeks&#xD;
Omaveloxolone Capsules, 160 mg</description>
          </group>
          <group group_id="O7">
            <title>Part 1 Omaveloxolone Capsules 300 mg</title>
            <description>Omaveloxolone (RTA 408) Capsules, 300 mg administered orally once daily for 12 weeks&#xD;
Omaveloxolone Capsules, 300 mg</description>
          </group>
          <group group_id="O8">
            <title>Part 1 Placebo Capsules</title>
            <description>Placebo capsules administered orally once daily for 12 weeks&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Peak Work (in Watts/kg) During Exercise Testing at Week 12 in Part 1</title>
          <description>Peak work attained during maximal exercise testing. Cycle ergometry using a recumbent stationary bicycle was used, and workload was increased incrementally. Peak work is defined as the workload at which patients reach maximal volition (defined as an inability to continue to exercise due to exhaustion).</description>
          <population>All randomized patients in Part 1, whether or not they received study drug</population>
          <units>W/kg</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="12"/>
                <count group_id="O7" value="10"/>
                <count group_id="O8" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.14" lower_limit="0.02" upper_limit="0.26"/>
                    <measurement group_id="O2" value="0.07" lower_limit="-0.05" upper_limit="0.18"/>
                    <measurement group_id="O3" value="-0.09" lower_limit="-0.20" upper_limit="0.03"/>
                    <measurement group_id="O4" value="0.06" lower_limit="-0.06" upper_limit="0.18"/>
                    <measurement group_id="O5" value="0" lower_limit="-0.11" upper_limit="0.12"/>
                    <measurement group_id="O6" value="0.02" lower_limit="-0.06" upper_limit="0.10"/>
                    <measurement group_id="O7" value="0.07" lower_limit="-0.02" upper_limit="0.17"/>
                    <measurement group_id="O8" value="0.04" lower_limit="-0.03" upper_limit="0.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1524</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Treatment group, time, and the interaction between treatment and time were used as fixed factors.</method_desc>
            <param_type>LS Mean difference (Net)</param_type>
            <param_value>0.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.04</ci_lower_limit>
            <ci_upper_limit>0.23</ci_upper_limit>
            <estimate_desc>Difference is omaveloxolone - placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7086</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Treatment group, time, and the interaction between treatment and time were used as fixed factors.</method_desc>
            <param_type>LS Mean difference (Net)</param_type>
            <param_value>0.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.11</ci_lower_limit>
            <ci_upper_limit>0.16</ci_upper_limit>
            <estimate_desc>Difference is omaveloxolone - placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0651</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Treatment group, time, and the interaction between treatment and time were used as fixed factors.</method_desc>
            <param_type>LS Mean difference (Net)</param_type>
            <param_value>-0.13</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.26</ci_lower_limit>
            <ci_upper_limit>0.01</ci_upper_limit>
            <estimate_desc>Difference is omaveloxolone - placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7937</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Treatment group, time, and the interaction between treatment and time were used as fixed factors.</method_desc>
            <param_type>LS Mean difference (Net)</param_type>
            <param_value>0.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.12</ci_lower_limit>
            <ci_upper_limit>0.15</ci_upper_limit>
            <estimate_desc>Difference is omaveloxolone - placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5587</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Treatment group, time, and the interaction between treatment and time were used as fixed factors.</method_desc>
            <param_type>LS Mean difference (Net)</param_type>
            <param_value>-0.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.18</ci_lower_limit>
            <ci_upper_limit>0.10</ci_upper_limit>
            <estimate_desc>Difference is omaveloxolone - placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O6</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7285</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Treatment group, time, and the interaction between treatment and time were used as fixed factors.</method_desc>
            <param_type>LS Mean difference (Net)</param_type>
            <param_value>-0.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.13</ci_lower_limit>
            <ci_upper_limit>0.09</ci_upper_limit>
            <estimate_desc>Difference is omaveloxolone - placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O7</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5802</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Treatment group, time, and the interaction between treatment and time were used as fixed factors.</method_desc>
            <param_type>LS Mean difference (Net)</param_type>
            <param_value>0.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.09</ci_lower_limit>
            <ci_upper_limit>0.15</ci_upper_limit>
            <estimate_desc>Difference is omaveloxolone - placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
              <group_id>O7</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <groups_desc>Comparison of Omaveloxolone capsules pooled with Placebo capsules</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9698</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Treatment group, time, and the interaction between treatment and time were used as fixed factors.</method_desc>
            <param_type>LS Mean difference (Net)</param_type>
            <param_value>-0.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.08</ci_lower_limit>
            <ci_upper_limit>0.08</ci_upper_limit>
            <estimate_desc>Difference is omaveloxolone - placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in the Modified Friedreich's Ataxia Rating Scale (mFARS) at Week 48 in Part 2</title>
        <description>The mFARS includes 4 of the 5 sections of the Friedreich's Ataxia Rating Scale (FARS): bulbar (score 0 to 11), upper limb coordination (score 0 to 36), lower limb coordination (score 0 to 16), and upright stability (score 0 to 36). The minimum score is 0 and the maximum score is 99. A lower score indicates better neurological function.</description>
        <time_frame>48 weeks after participant receives the first dose in Part 2</time_frame>
        <population>Full analysis set (all patients in Part 2 randomized without pes cavus who have at least one post-baseline measurement)</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2 Placebo Capsules</title>
            <description>Placebo capsules administered orally once daily for 48 weeks&#xD;
Placebo</description>
          </group>
          <group group_id="O2">
            <title>Part 2 Omaveloxolone Capsules 150 mg</title>
            <description>Omaveloxolone (RTA 408) Capsules, 150 mg administered orally once daily for 48 weeks&#xD;
Omaveloxolone Capsules, 150 mg</description>
          </group>
        </group_list>
        <measure>
          <title>Change in the Modified Friedreich's Ataxia Rating Scale (mFARS) at Week 48 in Part 2</title>
          <description>The mFARS includes 4 of the 5 sections of the Friedreich's Ataxia Rating Scale (FARS): bulbar (score 0 to 11), upper limb coordination (score 0 to 36), lower limb coordination (score 0 to 16), and upright stability (score 0 to 36). The minimum score is 0 and the maximum score is 99. A lower score indicates better neurological function.</description>
          <population>Full analysis set (all patients in Part 2 randomized without pes cavus who have at least one post-baseline measurement)</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.85" spread="0.640"/>
                    <measurement group_id="O2" value="-1.55" spread="0.689"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0141</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Fixed factors: treatment group, time, interaction between treatment and time, interaction between baseline and time; covariates: site, baseline mFARS</method_desc>
            <param_type>LS Mean difference (Net)</param_type>
            <param_value>-2.40</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.956</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.31</ci_lower_limit>
            <ci_upper_limit>-0.50</ci_upper_limit>
            <estimate_desc>Difference is omaveloxolone - placebo.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in the Modified Friedreich's Ataxia Rating Scale (mFARS) at Week 12 in Part 1</title>
        <description>The mFARS includes 4 of the 5 sections of the Friedreich's Ataxia Rating Scale (FARS): bulbar (score 0 to 11), upper limb coordination (score 0 to 36), lower limb coordination (score 0 to 16), and upright stability (score 0 to 36). The minimum score is 0 and the maximum score is 99. A lower score indicates better neurological function.</description>
        <time_frame>12 weeks after participant receives the first dose in Part 1</time_frame>
        <population>All randomized patients in Part 1, whether or not they received study drug</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1 Omaveloxolone Capsules 2.5 and 5 mg</title>
            <description>Omaveloxolone (RTA 408) Capsules, 2.5 mg administered orally one daily for 2 weeks, then 5 mg administered orally once daily for 10 weeks&#xD;
Omaveloxolone Capsules, 2.5 mg&#xD;
Omaveloxolone Capsules, 5 mg</description>
          </group>
          <group group_id="O2">
            <title>Part 1 Omaveloxolone Capsules 10 mg</title>
            <description>Omaveloxolone (RTA 408) Capsules, 10 mg administered orally once daily for 12 weeks&#xD;
Omaveloxolone Capsules, 10 mg</description>
          </group>
          <group group_id="O3">
            <title>Part 1 Omaveloxolone Capsules 20 mg</title>
            <description>Omaveloxolone (RTA 408) Capsules, 20 mg administered orally once daily for 12 weeks&#xD;
Omaveloxolone Capsules, 20 mg</description>
          </group>
          <group group_id="O4">
            <title>Part 1 Omaveloxolone Capsules 40 mg</title>
            <description>Omaveloxolone (RTA 408) Capsules, 40 mg administered orally once daily for 12 weeks&#xD;
Omaveloxolone Capsules, 40 mg</description>
          </group>
          <group group_id="O5">
            <title>Part 1 Omaveloxolone Capsules 80 mg</title>
            <description>Omaveloxolone (RTA 408) Capsules, 80 mg administered orally once daily for 12 weeks&#xD;
Omaveloxolone Capsules, 80 mg</description>
          </group>
          <group group_id="O6">
            <title>Part 1 Omaveloxolone Capsules 160 mg</title>
            <description>Omaveloxolone (RTA 408) Capsules, 160 mg administered orally once daily for 12 weeks&#xD;
Omaveloxolone Capsules, 160 mg</description>
          </group>
          <group group_id="O7">
            <title>Part 1 Omaveloxolone Capsules 300 mg</title>
            <description>Omaveloxolone (RTA 408) Capsules, 300 mg administered orally once daily for 12 weeks&#xD;
Omaveloxolone Capsules, 300 mg</description>
          </group>
          <group group_id="O8">
            <title>Part 1 Placebo Capsules</title>
            <description>Placebo capsules administered orally once daily for 12 weeks&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Change in the Modified Friedreich's Ataxia Rating Scale (mFARS) at Week 12 in Part 1</title>
          <description>The mFARS includes 4 of the 5 sections of the Friedreich's Ataxia Rating Scale (FARS): bulbar (score 0 to 11), upper limb coordination (score 0 to 36), lower limb coordination (score 0 to 16), and upright stability (score 0 to 36). The minimum score is 0 and the maximum score is 99. A lower score indicates better neurological function.</description>
          <population>All randomized patients in Part 1, whether or not they received study drug</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="12"/>
                <count group_id="O7" value="10"/>
                <count group_id="O8" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.26" lower_limit="-5.82" upper_limit="-0.70"/>
                    <measurement group_id="O2" value="-1.97" lower_limit="-4.53" upper_limit="0.59"/>
                    <measurement group_id="O3" value="-2.44" lower_limit="-5.00" upper_limit="0.12"/>
                    <measurement group_id="O4" value="-2.4" lower_limit="-4.96" upper_limit="0.16"/>
                    <measurement group_id="O5" value="-2.88" lower_limit="-5.44" upper_limit="-0.31"/>
                    <measurement group_id="O6" value="-3.75" lower_limit="-5.56" upper_limit="-1.94"/>
                    <measurement group_id="O7" value="-0.88" lower_limit="-2.86" upper_limit="1.11"/>
                    <measurement group_id="O8" value="-1.43" lower_limit="-2.97" upper_limit="0.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2310</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Treatment group, time, and the interaction between treatment and time were used as fixed factors.</method_desc>
            <param_type>LS Mean difference (Net)</param_type>
            <param_value>-1.81</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.80</ci_lower_limit>
            <ci_upper_limit>1.18</ci_upper_limit>
            <estimate_desc>Difference is omaveloxolone - placebo.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7298</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Treatment group, time, and the interaction between treatment and time were used as fixed factors.</method_desc>
            <param_type>LS Mean difference (Net)</param_type>
            <param_value>-0.52</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.51</ci_lower_limit>
            <ci_upper_limit>2.47</ci_upper_limit>
            <estimate_desc>Difference is omaveloxolone - placebo.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5102</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Treatment group, time, and the interaction between treatment and time were used as fixed factors.</method_desc>
            <param_type>LS Mean difference (Net)</param_type>
            <param_value>-0.99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.99</ci_lower_limit>
            <ci_upper_limit>2.00</ci_upper_limit>
            <estimate_desc>Difference is omaveloxolone - placebo.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5281</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Treatment group, time, and the interaction between treatment and time were used as fixed factors.</method_desc>
            <param_type>LS Mean difference (Net)</param_type>
            <param_value>-0.95</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.94</ci_lower_limit>
            <ci_upper_limit>2.04</ci_upper_limit>
            <estimate_desc>Difference is omaveloxolone - placebo.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3458</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Treatment group, time, and the interaction between treatment and time were used as fixed factors.</method_desc>
            <param_type>LS Mean difference (Net)</param_type>
            <param_value>-1.42</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.42</ci_lower_limit>
            <ci_upper_limit>1.57</ci_upper_limit>
            <estimate_desc>Difference is omaveloxolone - placebo.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O6</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0587</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Treatment group, time, and the interaction between treatment and time were used as fixed factors.</method_desc>
            <param_type>LS Mean difference (Net)</param_type>
            <param_value>-2.30</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.68</ci_lower_limit>
            <ci_upper_limit>0.09</ci_upper_limit>
            <estimate_desc>Difference is omaveloxolone - placebo.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O7</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6480</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Treatment group, time, and the interaction between treatment and time were used as fixed factors.</method_desc>
            <param_type>LS Mean difference (Net)</param_type>
            <param_value>0.58</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.94</ci_lower_limit>
            <ci_upper_limit>3.10</ci_upper_limit>
            <estimate_desc>Difference is omaveloxolone - placebo.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
              <group_id>O7</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <groups_desc>Comparison of Omaveloxolone capsules pooled with Placebo capsules</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2174</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Treatment group, time, and the interaction between treatment and time were used as fixed factors.</method_desc>
            <param_type>LS Mean difference (Net)</param_type>
            <param_value>-1.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.87</ci_lower_limit>
            <ci_upper_limit>0.66</ci_upper_limit>
            <estimate_desc>Difference is omaveloxolone - placebo.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>16 weeks for Part 1 and 52 weeks for Part 2</time_frame>
      <desc>After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.</desc>
      <group_list>
        <group group_id="E1">
          <title>Part 1 Omaveloxolone Capsules 2.5 and 5 mg</title>
          <description>Omaveloxolone (RTA 408) Capsules, 2.5 mg administered orally one daily for 2 weeks, then 5 mg administered orally once daily for 10 weeks&#xD;
Omaveloxolone Capsules, 2.5 mg&#xD;
Omaveloxolone Capsules, 5 mg</description>
        </group>
        <group group_id="E2">
          <title>Part 1 Omaveloxolone Capsules 10 mg</title>
          <description>Omaveloxolone (RTA 408) Capsules, 10 mg administered orally once daily for 12 weeks&#xD;
Omaveloxolone Capsules, 10 mg</description>
        </group>
        <group group_id="E3">
          <title>Part 1 Omaveloxolone Capsules 20 mg</title>
          <description>Omaveloxolone (RTA 408) Capsules, 20 mg administered orally once daily for 12 weeks&#xD;
Omaveloxolone Capsules, 20 mg</description>
        </group>
        <group group_id="E4">
          <title>Part 1 Omaveloxolone Capsules 40 mg</title>
          <description>Omaveloxolone (RTA 408) Capsules, 40 mg administered orally once daily for 12 weeks&#xD;
Omaveloxolone Capsules, 40 mg</description>
        </group>
        <group group_id="E5">
          <title>Part 1 Omaveloxolone Capsules 80 mg</title>
          <description>Omaveloxolone (RTA 408) Capsules, 80 mg administered orally once daily for 12 weeks&#xD;
Omaveloxolone Capsules, 80 mg</description>
        </group>
        <group group_id="E6">
          <title>Part 1 Omaveloxolone Capsules 160 mg</title>
          <description>Omaveloxolone (RTA 408) Capsules, 160 mg administered orally once daily for 12 weeks&#xD;
Omaveloxolone Capsules, 160 mg</description>
        </group>
        <group group_id="E7">
          <title>Part 1 Omaveloxolone Capsules 300 mg</title>
          <description>Omaveloxolone (RTA 408) Capsules, 300 mg administered orally once daily for 12 weeks&#xD;
Omaveloxolone Capsules, 300 mg</description>
        </group>
        <group group_id="E8">
          <title>Part 1 Placebo Capsules</title>
          <description>Placebo capsules administered orally once daily for 12 weeks&#xD;
Placebo</description>
        </group>
        <group group_id="E9">
          <title>Part 2 Placebo Capsules</title>
          <description>Placebo capsules administered orally once daily for 48 weeks&#xD;
Placebo</description>
        </group>
        <group group_id="E10">
          <title>Part 2 Omaveloxolone Capsules 150 mg</title>
          <description>Omaveloxolone (RTA 408) Capsules, 150 mg administered orally once daily for 48 weeks&#xD;
Omaveloxolone Capsules, 150 mg</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (14.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E10" subjects_affected="5" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="2" subjects_affected="1" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Ventricular tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Drug withdrawal syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Gallbladder disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Laryngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Ankle fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Burns third degree</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Craniocerebral injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_vocab>MedDRA (14.1)</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="6" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="11" subjects_at_risk="12"/>
                <counts group_id="E7" subjects_affected="10" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="16" subjects_at_risk="17"/>
                <counts group_id="E9" subjects_affected="52" subjects_at_risk="52"/>
                <counts group_id="E10" subjects_affected="51" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E10" events="4" subjects_affected="1" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Ventricular extrasystoles</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Friedreich's ataxia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="2" subjects_affected="2" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Ocular hyperaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="3" subjects_affected="3" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="2" subjects_affected="2" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="2" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E9" events="3" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E10" events="21" subjects_affected="11" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="3" subjects_affected="3" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Abnormal faeces</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="2" subjects_affected="2" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E9" events="6" subjects_affected="5" subjects_at_risk="52"/>
                <counts group_id="E10" events="12" subjects_affected="10" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E10" events="2" subjects_affected="2" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="2" subjects_affected="2" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E7" events="3" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E9" events="8" subjects_affected="7" subjects_at_risk="52"/>
                <counts group_id="E10" events="22" subjects_affected="17" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="6" subjects_affected="6" subjects_at_risk="52"/>
                <counts group_id="E10" events="9" subjects_affected="8" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Energy increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E9" events="7" subjects_affected="7" subjects_at_risk="52"/>
                <counts group_id="E10" events="11" subjects_affected="11" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Gait disturbance</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="3" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E10" events="2" subjects_affected="2" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E10" events="3" subjects_affected="3" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="6" subjects_affected="4" subjects_at_risk="52"/>
                <counts group_id="E10" events="2" subjects_affected="2" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="11" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Gastrointestinal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E10" events="4" subjects_affected="3" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Gastrointestinal viral infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E10" events="8" subjects_affected="5" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E7" events="3" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="13" subjects_affected="9" subjects_at_risk="52"/>
                <counts group_id="E10" events="7" subjects_affected="7" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Pharyngitis streptococcal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="3" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E10" events="2" subjects_affected="1" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" events="3" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E6" events="4" subjects_affected="4" subjects_at_risk="12"/>
                <counts group_id="E7" events="10" subjects_affected="6" subjects_at_risk="10"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E9" events="29" subjects_affected="15" subjects_at_risk="52"/>
                <counts group_id="E10" events="20" subjects_affected="14" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="5" subjects_affected="4" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="3" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E10" events="2" subjects_affected="1" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Burns second degree</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="3" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Burns third degree</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Concussion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E10" events="2" subjects_affected="2" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="43" subjects_affected="19" subjects_at_risk="52"/>
                <counts group_id="E10" events="29" subjects_affected="17" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Excoriation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E9" events="21" subjects_affected="12" subjects_at_risk="52"/>
                <counts group_id="E10" events="18" subjects_affected="13" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Face injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Foot fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E10" events="2" subjects_affected="2" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Head injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Joint dislocation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Joint injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="3" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E10" events="4" subjects_affected="4" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="10" subjects_affected="8" subjects_at_risk="52"/>
                <counts group_id="E10" events="16" subjects_affected="8" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="3" subjects_affected="3" subjects_at_risk="17"/>
                <counts group_id="E9" events="12" subjects_affected="8" subjects_at_risk="52"/>
                <counts group_id="E10" events="7" subjects_affected="5" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E10" events="5" subjects_affected="5" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Muscle strain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="3" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E10" events="3" subjects_affected="3" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Periorbital haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Sunburn</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Thermal burn</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E10" events="20" subjects_affected="19" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E10" events="12" subjects_affected="11" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="3" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E10" events="4" subjects_affected="3" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Brain natriuretic peptide increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E7" events="3" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="4" subjects_affected="3" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Glucose urine present</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Liver function test abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Very low density lipoprotein increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="2" subjects_affected="2" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E10" events="6" subjects_affected="6" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Hypertriglyceridaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="2" subjects_affected="2" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Increased appetite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="13" subjects_affected="10" subjects_at_risk="52"/>
                <counts group_id="E10" events="10" subjects_affected="9" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="6" subjects_affected="4" subjects_at_risk="52"/>
                <counts group_id="E10" events="9" subjects_affected="7" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Exostosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E9" events="3" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E10" events="13" subjects_affected="8" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Muscle twitching</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="2" subjects_affected="2" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E9" events="4" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Musculoskeletal stiffness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E10" events="2" subjects_affected="2" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E9" events="3" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="3" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E9" events="4" subjects_affected="4" subjects_at_risk="52"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Pain in jaw</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="2" subjects_affected="2" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Autonomic nervous system imbalance</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="6" subjects_affected="6" subjects_at_risk="52"/>
                <counts group_id="E10" events="3" subjects_affected="3" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E6" events="4" subjects_affected="4" subjects_at_risk="12"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E8" events="3" subjects_affected="3" subjects_at_risk="17"/>
                <counts group_id="E9" events="35" subjects_affected="13" subjects_at_risk="52"/>
                <counts group_id="E10" events="30" subjects_affected="19" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="3" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Muscle spasticity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="2" subjects_affected="2" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Psychomotor hyperactivity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="2" subjects_affected="2" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="3" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Euphoric mood</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E9" events="4" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E10" events="3" subjects_affected="3" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Micturition urgency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Dysmenorrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="7" subjects_affected="3" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Ovarian cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="2" subjects_affected="2" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Choking</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E9" events="4" subjects_affected="4" subjects_at_risk="52"/>
                <counts group_id="E10" events="6" subjects_affected="6" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="6" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E10" events="2" subjects_affected="2" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E9" events="4" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E10" events="2" subjects_affected="2" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E9" events="3" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E10" events="10" subjects_affected="9" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Paranasal sinus hypersecretion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Pulmonary congestion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="4" subjects_affected="2" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E10" events="2" subjects_affected="2" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Petechiae</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="2" subjects_affected="2" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E10" events="3" subjects_affected="1" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Rash generalised</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Rash macular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="2" subjects_affected="2" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Skin exfoliation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="5" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </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>Sponsor can review results communications prior to public release and can embargo communications regarding trial results for up to a period that is more than 60 days but less than or equal to 180 days. Sponsor can require changes to the results communication where confidential information that would put Sponsor at a competitive disadvantage occurs. PI may publish results after a multi-investigator publication or 12 months following completion of the trial, whichever is earlier.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Affairs</name_or_title>
      <organization>Reata Pharmaceuticals, Inc.</organization>
      <phone>+1-833-633-2666</phone>
      <email>Medical.Communications@reatapharma.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/NCT02255435
org study id: RTA 408-C-1402
nct id: NCT02255435
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
Friedreich's ataxia is an autosomal recessive cerebellar ataxia caused by triplet-repeat
      expansions. The causative mutation is a trinucleotide (GAA) repeat expansion in the first
      intron of the frataxin gene, leading to impaired transcription of frataxin. The pathological
      consequences of frataxin deficiency include a severe disruption of iron-sulfur cluster
      biosynthesis, mitochondrial iron overload coupled to cellular iron dysregulation, and an
      increased sensitivity to oxidative stress.

      A hallmark of Friedreich's ataxia is impairment of antioxidative defense mechanisms, which
      play a major role in disease progression. Studies have demonstrated that nuclear factor
      erythroid-derived 2-related factor 2 (Nrf2) signaling is grossly impaired in patients with
      Friedreich's ataxia. Therefore, the ability of omaveloxolone (RTA 408) to activate Nrf2 and
      induce antioxidant target genes is hypothesized to be therapeutic in patients with
      Friedreich's ataxia.

      This 2-part study will evaluate the efficacy, safety, and pharmacodynamics of omaveloxolone
      (RTA 408) in the treatment of patients with Friedreich's ataxia.

      Part 1: The first part of this study will be a randomized, placebo-controlled, double-blind,
      dose-escalation study to evaluate the safety of omaveloxolone (RTA 408) at various doses in
      patients with Friedreich's ataxia.

      Part 2: The second part of this study is a randomized, placebo-controlled, double-blind,
      parallel-group study to evaluate the safety and efficacy of omaveloxolone (RTA 408) 150 mg in
      patients with Friedreich's ataxia. Patients enrolled in Part 2 will be randomized 1:1 to
      receive omaveloxolone (RTA 408) 150 mg or placebo.

      Extension: The extension will assess long-term safety and tolerability of omaveloxolone (RTA
      408) in qualified patients with Friedreich's ataxia following completion of Part 1 or Part 2.
      Patients will not be unblinded to study treatment in Part 1 or Part 2 upon entering the
      extension study. Patients will receive open-label omaveloxolone (RTA 408) at 150 mg once
      daily.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change From Baseline in Peak Work (in Watts/kg) During Exercise Testing at Week 12 in Part 1
time frame: Baseline through 12 weeks after participant receives the first dose in Part 1.
description: Peak work attained during maximal exercise testing. Cycle ergometry using a recumbent stationary bicycle was used, and workload was increased incrementally. Peak work is defined as the workload at which patients reach maximal volition (defined as an inability to continue to exercise due to exhaustion).
measure: Change in the Modified Friedreich's Ataxia Rating Scale (mFARS) at Week 48 in Part 2
time frame: 48 weeks after participant receives the first dose in Part 2
description: The mFARS includes 4 of the 5 sections of the Friedreich's Ataxia Rating Scale (FARS): bulbar (score 0 to 11), upper limb coordination (score 0 to 36), lower limb coordination (score 0 to 16), and upright stability (score 0 to 36). The minimum score is 0 and the maximum score is 99. A lower score indicates better neurological function.
measure: Change in the Modified Friedreich's Ataxia Rating Scale (mFARS) at Week 12 in Part 1
time frame: 12 weeks after participant receives the first dose in Part 1
description: The mFARS includes 4 of the 5 sections of the Friedreich's Ataxia Rating Scale (FARS): bulbar (score 0 to 11), upper limb coordination (score 0 to 36), lower limb coordination (score 0 to 16), and upright stability (score 0 to 36). The minimum score is 0 and the maximum score is 99. A lower score indicates better neurological function.
arm group label: Part 1 Omaveloxolone Capsules 2.5 and 5 mg
arm group type: Experimental
description: omaveloxolone (RTA 408) Capsules, 2.5 mg administered orally one daily for 2 weeks, then 5 mg taken orally once daily for 10 weeks
arm group label: Part 1 Omaveloxolone Capsules 10 mg
arm group type: Experimental
description: omaveloxolone (RTA 408) Capsules, 10 mg administered orally once daily for 12 weeks
arm group label: Part 1 Omaveloxolone Capsules 20 mg
arm group type: Experimental
description: Omaveloxolone (RTA 408) Capsules, 20 mg administered orally once daily for 12 weeks
arm group label: Part 1 Omaveloxolone Capsules 40 mg
arm group type: Experimental
description: Omaveloxolone (RTA 408) Capsules, 40 mg administered orally once daily for 12 weeks
arm group label: Part 1 Omaveloxolone Capsules 80 mg
arm group type: Experimental
description: Omaveloxolone (RTA 408) Capsules, 80 mg administered orally once daily for 12 weeks
arm group label: Part 1 Omaveloxolone Capsules 160 mg
arm group type: Experimental
description: Omaveloxolone (RTA 408) Capsules, 160 mg administered orally once daily for 12 weeks
arm group label: Part 1 Omaveloxolone Capsules 300 mg
arm group type: Experimental
description: Omaveloxolone (RTA 408) Capsules, 300 mg administered orally once daily for 12 weeks
arm group label: Part 1 Placebo Capsules
arm group type: Placebo Comparator
description: Placebo capsules administered orally once daily for 12 weeks
arm group label: Part 2 Placebo Capsules
arm group type: Placebo Comparator
description: Placebo capsules administered orally once daily for 48 weeks
arm group label: Part 2 Omaveloxolone Capsules 150 mg
arm group type: Experimental
description: Omaveloxolone (RTA 408) Capsules, 150 mg administered orally once daily for 48 weeks
intervention type: Drug
intervention name: Omaveloxolone Capsules, 2.5 mg
arm group label: Part 1 Omaveloxolone Capsules 2.5 and 5 mg
other name: RTA 408 Capsules 2.5 mg
intervention type: Drug
intervention name: Omaveloxolone Capsules, 5 mg
arm group label: Part 1 Omaveloxolone Capsules 2.5 and 5 mg
other name: RTA 408 capsules, 5 mg
intervention type: Drug
intervention name: Omaveloxolone Capsules, 10 mg
arm group label: Part 1 Omaveloxolone Capsules 10 mg
other name: RTA 408 capsules, 10 mg
intervention type: Drug
intervention name: Placebo
arm group label: Part 1 Placebo Capsules
arm group label: Part 2 Placebo Capsules
intervention type: Drug
intervention name: Omaveloxolone Capsules, 20 mg
arm group label: Part 1 Omaveloxolone Capsules 20 mg
other name: RTA 408 capsules, 20 mg
intervention type: Drug
intervention name: Omaveloxolone Capsules, 40 mg
arm group label: Part 1 Omaveloxolone Capsules 40 mg
other name: RTA 408 capsules, 40 mg
intervention type: Drug
intervention name: Omaveloxolone Capsules, 80 mg
arm group label: Part 1 Omaveloxolone Capsules 80 mg
other name: RTA 408 capsules, 80 mg
intervention type: Drug
intervention name: Omaveloxolone Capsules, 160 mg
arm group label: Part 1 Omaveloxolone Capsules 160 mg
other name: RTA 408 capsules, 160 mg
intervention type: Drug
intervention name: Omaveloxolone Capsules, 300 mg
arm group label: Part 1 Omaveloxolone Capsules 300 mg
other name: RTA 408 capsules, 300 mg
intervention type: Drug
intervention name: Omaveloxolone Capsules, 150 mg
arm group label: Part 2 Omaveloxolone Capsules 150 mg
other name: RTA 408 capsules, 150 mg
criteria: 
gender: All
minimum age: 16 Years
maximum age: 40 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Australia
country: Austria
country: Italy
country: United Kingdom
country: United States
country: Brazil
responsible party type: Sponsor
mesh term: Ataxia
mesh term: Cerebellar Ataxia
mesh term: Friedreich Ataxia
provided document: 
provided document: 
provided document: 
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 