<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/NCT03812029</url>
  </required_header>
  <id_info>
    <org_study_id>EYP001-202</org_study_id>
    <secondary_id>2018-003119-22</secondary_id>
    <nct_id>NCT03812029</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability, Pharmacokinetics and Efficacy of EYP001a in Patients With Nonalcoholic Steatohepatitis (NASH)</brief_title>
  <official_title>A Phase 2a, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of EYP001a in Patients With Nonalcoholic Steatohepatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Enyo Pharma</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Enyo Pharma</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the effects of EYP001a (Vonafexor) with respect to&#xD;
      safety, tolerability, pharmacokinetics and on markers of liver inflammation in patients with&#xD;
      NASH&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a 2-part, randomized, double-blind, multicenter, placebo-controlled study to evaluate&#xD;
      the safety and efficacy of Vonafexor in patients with NASH who likely have stage F2 to F3&#xD;
      fibrosis at approximately 50 global clinical sites. Overall, approximately 114 eligible&#xD;
      patients will be enrolled: 24 patients in Part A (Safety Run-in Cohort), followed by 90&#xD;
      patients in Part B.&#xD;
&#xD;
      In Part A, 24 patients will be randomized on Day 1 to 1 of 4 parallel treatment groups: 100&#xD;
      mg Vonafexor twice daily (BID), 200 mg Vonafexor once daily (QD), 400 mg Vonafexor QD, or&#xD;
      placebo BID. In Part B, 90 patients will be randomized on Day 1 to 1 of 3 parallel treatment&#xD;
      groups: 100 mg Vonafexor QD, 200 mg Vonafexor QD, or placebo QD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 30, 2019</start_date>
  <completion_date type="Actual">July 6, 2021</completion_date>
  <primary_completion_date type="Actual">June 16, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Parallel assignment</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>Triple (Participant, Care Provider, Investigator)</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Analysis of Absolute Change From Baseline in Percentage of Fat in the Liver as Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)</measure>
    <time_frame>12 weeks</time_frame>
    <description>The liver fat percentage was assessed by MRI-PDFF, which is an established method that enables the quantification of fat content in the liver; the value of liver fat is expressed in percentage and ranges from 0 to 100% with higher values representing higher liver fat level.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Analysis of Change From Baseline in Glomerular Filtration rate_Part B</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of Percent Change (Relative) From Baseline in Percentage of Fat in the Liver as Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)</measure>
    <time_frame>12 weeks</time_frame>
    <description>The liver fat percentage was assessed by MRI-PDFF, which is an established method that enables the quantification of fat content in the liver; the value of liver fat is expressed in percentage and ranges from 0 to 100% with higher values representing higher liver fat level.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of Change From Baseline in Corrected T1 (CT1)</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of Change From Baseline in Alanine Aminotransferase (ALT)</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of Change From Baseline in Gamma Glutamyltranspeptidase (GT)</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of Change From Baseline in Body Weight</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of Change From Baseline in Waist Circumference</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of Change From Baseline in Waist to Hip ratio_Part B</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of Change From Baseline in Glomerular Filtration rate_Part A</measure>
    <time_frame>12 weeks</time_frame>
    <description>For Part A, as per ICH, analysis were performed as defined in the SAP: data from the 3 vonafexor treatment groups were pooled and compared with the placebo group.</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Non-alcoholic Steatohepatitis</condition>
  <arm_group>
    <arm_group_label>Vonafexor 100 mg BID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral dose twice daily for 12 weeks (84 days)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vonafexor 200 mg QD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral dose once daily for 12 weeks (84 days)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vonafexor 400 mg QD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral dose once daily for 12 weeks (84 days)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Oral dose twice daily for 12 weeks (84 days)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vonafexor 100 mg QD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral dose once daily for 12 weeks (84 days)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vonafexor</intervention_name>
    <description>Oral tablets</description>
    <arm_group_label>Vonafexor 100 mg BID</arm_group_label>
    <arm_group_label>Vonafexor 100 mg QD</arm_group_label>
    <arm_group_label>Vonafexor 200 mg QD</arm_group_label>
    <arm_group_label>Vonafexor 400 mg QD</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Oral tablets</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
          -  Suspected diagnosis of NASH, evidenced by elevated alanine aminotransferase (ALT),&#xD;
             liver stiffness compatible with F2 or F3 fibrosis and Liver Fat Content (LFC) ≥10% as&#xD;
             measured by MRI&#xD;
&#xD;
          -  Women of childbearing potential and male patients with female partners must agree to&#xD;
             use a dual method of contraception&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence of worsening liver injury&#xD;
&#xD;
          -  Previous diagnosis of other forms of non-NASH liver disease&#xD;
&#xD;
          -  Use of Vitamin E, glitazones, glucagon-like Peptide-1 receptor agonists,&#xD;
             ursodeoxycholic acid, or obeticholic acid within 90 days prior to screening&#xD;
&#xD;
          -  History of cirrhosis or liver decompensation&#xD;
&#xD;
          -  Known history of alcohol abuse or daily heavy alcohol consumption&#xD;
&#xD;
          -  Pregnant or breastfeeding women&#xD;
&#xD;
          -  Type 1 diabetes mellitus and uncontrolled type 2 diabetes mellitus&#xD;
&#xD;
          -  Patients with contraindications to MRI imaging&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Harrison Stephen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pinnacle Clinical Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site 0424</name>
      <address>
        <city>North Little Rock</city>
        <state>Arkansas</state>
        <zip>72117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site 0418</name>
      <address>
        <city>Lakewood Ranch</city>
        <state>Florida</state>
        <zip>34211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site 0402</name>
      <address>
        <city>Ocoee</city>
        <state>Florida</state>
        <zip>34761</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site 0420</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site 0419</name>
      <address>
        <city>Port Orange</city>
        <state>Florida</state>
        <zip>32127</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site 0403</name>
      <address>
        <city>Athens</city>
        <state>Georgia</state>
        <zip>30607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site 0423</name>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <zip>31406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site 0407</name>
      <address>
        <city>Snellville</city>
        <state>Georgia</state>
        <zip>30078</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site 0409</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site 0413</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70809</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site 0404</name>
      <address>
        <city>Marrero</city>
        <state>Louisiana</state>
        <zip>70072</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site 0422</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site 0412</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site 0414</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site 0406</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site 0411</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site 0401</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site 0408</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site 0421</name>
      <address>
        <city>Rapid City</city>
        <state>South Dakota</state>
        <zip>57701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site 0405</name>
      <address>
        <city>Arlington</city>
        <state>Texas</state>
        <zip>76012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site 0416</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78746</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site 0417</name>
      <address>
        <city>Edinburg</city>
        <state>Texas</state>
        <zip>78539</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site 0410</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site 0415</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site 0105</name>
      <address>
        <city>Brussels</city>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site 0101</name>
      <address>
        <city>Edegem</city>
        <zip>2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site 0104</name>
      <address>
        <city>Gent</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site 0103</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site 0201</name>
      <address>
        <city>Angers</city>
        <zip>49933</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site</name>
      <address>
        <city>Créteil</city>
        <zip>94010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site 0203</name>
      <address>
        <city>Limoges</city>
        <zip>87000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site 0204</name>
      <address>
        <city>Lyon</city>
        <zip>69004</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site 0206</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site 0202</name>
      <address>
        <city>Pessac</city>
        <zip>33600</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site 0207</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site 0205</name>
      <address>
        <city>Villejuif</city>
        <zip>94800</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site 0429</name>
      <address>
        <city>San Juan</city>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site 0304</name>
      <address>
        <city>Belfast</city>
        <zip>BT12 6BA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site 0302</name>
      <address>
        <city>Cambridge</city>
        <zip>CB2 0QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site 0303</name>
      <address>
        <city>London</city>
        <zip>E1 1BB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site 0305</name>
      <address>
        <city>London</city>
        <zip>SE5 9RS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site 0301</name>
      <address>
        <city>Nottingham</city>
        <zip>NG7 2UH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>France</country>
    <country>Puerto Rico</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <results_first_submitted>November 16, 2022</results_first_submitted>
  <results_first_submitted_qc>April 13, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">May 6, 2023</results_first_posted>
  <last_update_submitted>April 13, 2023</last_update_submitted>
  <last_update_submitted_qc>April 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>EYP001 (vonafexor)</keyword>
  <keyword>Liver Diseases</keyword>
  <keyword>Non-alcoholic Fatty Liver Disease</keyword>
  <keyword>Non-alcoholic Steatohepatitis</keyword>
  <keyword>NASH</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatty Liver</mesh_term>
    <mesh_term>Non-alcoholic Fatty Liver Disease</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 24, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/29/NCT03812029/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 2, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/29/NCT03812029/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>For Part A, data from the 3 vonafexor treatment groups were pooled and summarized. Due to the small number of subjects by treatment group in Part A, and as the Study EYP001 202 Part A Pharmacokinetic (PK) results between groups were found to be nonlinear with similar exposure for the vonafexor 200 mg once daily (QD) and vonafexor 400 mg QD groups, only the pooled vonafexor treatment group were compared with the placebo group.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo Part A</title>
          <description>Oral dose twice daily for 12 weeks (84 days)&#xD;
Placebo: Oral tablets</description>
        </group>
        <group group_id="P2">
          <title>Vonafexor Pooled Part A</title>
          <description>Oral dose once or twice a day according to treatment arm for 12 weeks (84 days)&#xD;
Vonafexor: Oral tablets</description>
        </group>
        <group group_id="P3">
          <title>Placebo Part B</title>
          <description>Oral dose once daily for 12 weeks (84 days)&#xD;
Placebo: Oral tablets</description>
        </group>
        <group group_id="P4">
          <title>Vonafexor 100 mg QD Part B</title>
          <description>Oral dose once daily for 12 weeks (84 days)&#xD;
Vonafexor: Oral tablets</description>
        </group>
        <group group_id="P5">
          <title>Vonafexor 200 mg QD Part B</title>
          <description>Oral dose once daily for 12 weeks (84 days)&#xD;
Vonafexor: Oral tablets</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="17"/>
                <participants group_id="P3" count="32"/>
                <participants group_id="P4" count="31"/>
                <participants group_id="P5" count="33"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="32"/>
                <participants group_id="P4" count="25"/>
                <participants group_id="P5" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Stopping rules</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</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="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>For Part A, data from the 3 vonafexor treatment groups were pooled and summarized. Due to the small number of subjects by treatment group in Part A, and as the Study EYP001 202 Part A PK results between groups were found to be nonlinear with similar exposure for the vonafexor 200 mg QD and vonafexor 400 mg QD groups, only the pooled vonafexor treatment group were compared with the placebo group.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo Part A</title>
          <description>Oral dose twice daily for 12 weeks (84 days)&#xD;
Placebo: Oral tablets</description>
        </group>
        <group group_id="B2">
          <title>Vonafexor Pooled Part A</title>
          <description>Oral dose once or twice a day according to treatment arms for 12 weeks (84 days)&#xD;
Vonafexor: Oral tablets</description>
        </group>
        <group group_id="B3">
          <title>Placebo Part B</title>
          <description>Oral dose once daily for 12 weeks (84 days)&#xD;
Placebo: Oral tablets</description>
        </group>
        <group group_id="B4">
          <title>Vonafexor 100 mg QD Part B</title>
          <description>Oral dose once daily for 12 weeks (84 days)&#xD;
Vonafexor: Oral tablets</description>
        </group>
        <group group_id="B5">
          <title>Vonafexor 200 mg QD Part B</title>
          <description>Oral dose once daily for 12 weeks (84 days)&#xD;
Vonafexor: Oral tablets</description>
        </group>
        <group group_id="B6">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="7"/>
            <count group_id="B2" value="17"/>
            <count group_id="B3" value="32"/>
            <count group_id="B4" value="31"/>
            <count group_id="B5" value="33"/>
            <count group_id="B6" value="120"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>Part A + Part B were analysed fully separately as per SAP and Study Protocol v5.0 with study populations slightly different between the 2 study parts.</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Age Part A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="7"/>
                    <count group_id="B2" value="17"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="0"/>
                    <count group_id="B5" value="0"/>
                    <count group_id="B6" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48.7" spread="18.4"/>
                    <measurement group_id="B2" value="56.1" spread="8.9"/>
                    <measurement group_id="B6" value="54.0" spread="12.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age Part B</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="32"/>
                    <count group_id="B4" value="31"/>
                    <count group_id="B5" value="33"/>
                    <count group_id="B6" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="57.3" spread="10.3"/>
                    <measurement group_id="B4" value="58.1" spread="13.7"/>
                    <measurement group_id="B5" value="54.0" spread="11.9"/>
                    <measurement group_id="B6" value="56.4" spread="12.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="7"/>
                    <count group_id="B2" value="17"/>
                    <count group_id="B3" value="32"/>
                    <count group_id="B4" value="31"/>
                    <count group_id="B5" value="33"/>
                    <count group_id="B6" value="120"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="14"/>
                    <measurement group_id="B5" value="21"/>
                    <measurement group_id="B6" value="69"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="17"/>
                    <measurement group_id="B5" value="12"/>
                    <measurement group_id="B6" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="7"/>
                    <count group_id="B2" value="17"/>
                    <count group_id="B3" value="32"/>
                    <count group_id="B4" value="31"/>
                    <count group_id="B5" value="33"/>
                    <count group_id="B6" value="120"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="10"/>
                    <measurement group_id="B6" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="26"/>
                    <measurement group_id="B4" value="23"/>
                    <measurement group_id="B5" value="23"/>
                    <measurement group_id="B6" value="89"/>
                  </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_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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="7"/>
                    <count group_id="B2" value="17"/>
                    <count group_id="B3" value="32"/>
                    <count group_id="B4" value="31"/>
                    <count group_id="B5" value="33"/>
                    <count group_id="B6" value="120"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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="1"/>
                    <measurement group_id="B6" value="1"/>
                  </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_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_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="29"/>
                    <measurement group_id="B4" value="26"/>
                    <measurement group_id="B5" value="31"/>
                    <measurement group_id="B6" value="109"/>
                  </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_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="3"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <population>Part A + Part B were analysed fully separately as per SAP and Study Protocol v5.0 with study populations slightly different between the 2 study parts.</population>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Height Part A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="7"/>
                    <count group_id="B2" value="17"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="0"/>
                    <count group_id="B5" value="0"/>
                    <count group_id="B6" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="169.0" spread="7.4"/>
                    <measurement group_id="B2" value="163.2" spread="9.9"/>
                    <measurement group_id="B6" value="164.9" spread="9.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Height Part B</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="32"/>
                    <count group_id="B4" value="31"/>
                    <count group_id="B5" value="33"/>
                    <count group_id="B6" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="168.1" spread="9.8"/>
                    <measurement group_id="B4" value="167.1" spread="8.5"/>
                    <measurement group_id="B5" value="166.8" spread="10.1"/>
                    <measurement group_id="B6" value="167.3" spread="9.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <population>Part A + Part B were analysed fully separately as per SAP and Study Protocol v5.0 with study populations slightly different between the 2 study parts.</population>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Weight Part A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="7"/>
                    <count group_id="B2" value="17"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="0"/>
                    <count group_id="B5" value="0"/>
                    <count group_id="B6" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="112.4" spread="32.6"/>
                    <measurement group_id="B2" value="103.4" spread="25.4"/>
                    <measurement group_id="B6" value="106.0" spread="27.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weight Part B</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="32"/>
                    <count group_id="B4" value="31"/>
                    <count group_id="B5" value="33"/>
                    <count group_id="B6" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="97.5" spread="18.3"/>
                    <measurement group_id="B4" value="95.8" spread="14.0"/>
                    <measurement group_id="B5" value="98.8" spread="18.4"/>
                    <measurement group_id="B6" value="97.4" spread="16.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <population>Part A + Part B were analysed fully separately as per SAP and Study Protocol v5.0 with study populations slightly different between the 2 study parts.</population>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>BMI Part A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="7"/>
                    <count group_id="B2" value="17"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="0"/>
                    <count group_id="B5" value="0"/>
                    <count group_id="B6" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39.3" spread="10.2"/>
                    <measurement group_id="B2" value="38.8" spread="9.0"/>
                    <measurement group_id="B6" value="38.9" spread="9.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BMI Part B</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="32"/>
                    <count group_id="B4" value="31"/>
                    <count group_id="B5" value="33"/>
                    <count group_id="B6" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="34.3" spread="4.3"/>
                    <measurement group_id="B4" value="34.3" spread="4.1"/>
                    <measurement group_id="B5" value="35.4" spread="5.1"/>
                    <measurement group_id="B6" value="34.7" spread="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Waist circumference</title>
          <population>Part A + Part B were analysed fully separately as per SAP and Study Protocol v5.0 with study populations slightly different between the 2 study parts.</population>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Waist circumference Part A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="7"/>
                    <count group_id="B2" value="17"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="0"/>
                    <count group_id="B5" value="0"/>
                    <count group_id="B6" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="128.9" spread="31.5"/>
                    <measurement group_id="B2" value="116.1" spread="16.0"/>
                    <measurement group_id="B6" value="119.8" spread="21.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Waist circumference Part B</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="32"/>
                    <count group_id="B4" value="31"/>
                    <count group_id="B5" value="33"/>
                    <count group_id="B6" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="112.6" spread="13.0"/>
                    <measurement group_id="B4" value="111.4" spread="8.6"/>
                    <measurement group_id="B5" value="114.1" spread="11.8"/>
                    <measurement group_id="B6" value="112.7" spread="11.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Analysis of Absolute Change From Baseline in Percentage of Fat in the Liver as Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)</title>
        <description>The liver fat percentage was assessed by MRI-PDFF, which is an established method that enables the quantification of fat content in the liver; the value of liver fat is expressed in percentage and ranges from 0 to 100% with higher values representing higher liver fat level.</description>
        <time_frame>12 weeks</time_frame>
        <population>For Part A, as per ICH, analysis were performed as defined in the SAP: data from the 3 vonafexor treatment groups were pooled and compared with the placebo group.&#xD;
The modified ITT (mITT) Population which was defined as patients from the ITT Population who have valid baseline and Week 12/Early Termination (ET) MRI-PDFF measurements of Liver Fat Content (LFC) has been used to analyse this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Part B</title>
            <description>Oral dose once daily for 12 weeks (84 days)&#xD;
Placebo: Oral tablets</description>
          </group>
          <group group_id="O2">
            <title>Vonafexor 100 mg QD Part B</title>
            <description>Oral dose once daily for 12 weeks (84 days)&#xD;
Vonafexor: Oral tablets</description>
          </group>
          <group group_id="O3">
            <title>Vonafexor 200 mg QD Part B</title>
            <description>Oral dose once daily for 12 weeks (84 days)&#xD;
Vonafexor: Oral tablets</description>
          </group>
          <group group_id="O4">
            <title>Placebo Part A</title>
            <description>Oral dose twice daily for 12 weeks (84 days)&#xD;
Placebo: Oral tablets</description>
          </group>
          <group group_id="O5">
            <title>Vonafexor Pooled Part A</title>
            <description>Oral dose once or twice a day according to treatment arms for 12 weeks (84 days)&#xD;
Vonafexor: Oral tablets</description>
          </group>
        </group_list>
        <measure>
          <title>Analysis of Absolute Change From Baseline in Percentage of Fat in the Liver as Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)</title>
          <description>The liver fat percentage was assessed by MRI-PDFF, which is an established method that enables the quantification of fat content in the liver; the value of liver fat is expressed in percentage and ranges from 0 to 100% with higher values representing higher liver fat level.</description>
          <population>For Part A, as per ICH, analysis were performed as defined in the SAP: data from the 3 vonafexor treatment groups were pooled and compared with the placebo group.&#xD;
The modified ITT (mITT) Population which was defined as patients from the ITT Population who have valid baseline and Week 12/Early Termination (ET) MRI-PDFF measurements of Liver Fat Content (LFC) has been used to analyse this endpoint.</population>
          <units>Percentage of liver fat change</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="32"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="28"/>
                <count group_id="O4" value="5"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.3" lower_limit="-4.0" upper_limit="-0.6"/>
                    <measurement group_id="O2" value="-6.3" lower_limit="-8.1" upper_limit="-4.5"/>
                    <measurement group_id="O3" value="-5.4" lower_limit="-7.2" upper_limit="-3.6"/>
                    <measurement group_id="O4" value="3.9" lower_limit="-2.5" upper_limit="10.4"/>
                    <measurement group_id="O5" value="-4.7" lower_limit="-8.5" upper_limit="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0015</p_value>
            <p_value_desc>a priori threshold for statistical significance : &lt;0.05.</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0121</p_value>
            <p_value_desc>a priori threshold for statistical significance : &lt;0.05.</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0371</p_value>
            <p_value_desc>a priori threshold for statistical significance : &lt;0.05.</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Analysis of Change From Baseline in Glomerular Filtration rate_Part B</title>
        <time_frame>12 weeks</time_frame>
        <population>The Intent-to-Treat (ITT) Population, which was defined as all patients who were randomized and administered at least 1 dose of study drug was used to analyse this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Part B</title>
            <description>Oral dose once daily for 12 weeks (84 days)&#xD;
Placebo: Oral tablets</description>
          </group>
          <group group_id="O2">
            <title>Vonafexor 100 mg QD Part B</title>
            <description>Oral dose once daily for 12 weeks (84 days)&#xD;
Vonafexor: Oral tablets</description>
          </group>
          <group group_id="O3">
            <title>Vonafexor 200 mg QD Part B</title>
            <description>Oral dose once daily for 12 weeks (84 days)&#xD;
Vonafexor: Oral tablets</description>
          </group>
        </group_list>
        <measure>
          <title>Analysis of Change From Baseline in Glomerular Filtration rate_Part B</title>
          <population>The Intent-to-Treat (ITT) Population, which was defined as all patients who were randomized and administered at least 1 dose of study drug was used to analyse this endpoint.</population>
          <units>mL/min/1.73m2</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="32"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.7" lower_limit="-6.6" upper_limit="1.2"/>
                    <measurement group_id="O2" value="6.2" lower_limit="1.9" upper_limit="10.2"/>
                    <measurement group_id="O3" value="3.2" lower_limit="-1.2" upper_limit="7.7"/>
                  </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>0.003</p_value>
            <p_value_desc>a priori threshold for statistical significance : &lt;0.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.04</p_value>
            <p_value_desc>a priori threshold for statistical significance : &lt;0.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Analysis of Percent Change (Relative) From Baseline in Percentage of Fat in the Liver as Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)</title>
        <description>The liver fat percentage was assessed by MRI-PDFF, which is an established method that enables the quantification of fat content in the liver; the value of liver fat is expressed in percentage and ranges from 0 to 100% with higher values representing higher liver fat level.</description>
        <time_frame>12 weeks</time_frame>
        <population>For Part A, as per ICH, analysis were performed as defined in the SAP: data from the 3 vonafexor treatment groups were pooled and compared with the placebo group.&#xD;
The modified ITT (mITT) Population which was defined as patients from the ITT Population who have valid baseline and Week 12/ET MRI-PDFF measurements of LFC has been used to analyse this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Part B</title>
            <description>Oral dose once daily for 12 weeks (84 days)&#xD;
Placebo: Oral tablets</description>
          </group>
          <group group_id="O2">
            <title>Vonafexor 100 mg QD Part B</title>
            <description>Oral dose once daily for 12 weeks (84 days)&#xD;
Vonafexor: Oral tablets</description>
          </group>
          <group group_id="O3">
            <title>Vonafexor 200 mg QD Part B</title>
            <description>Oral dose once daily for 12 weeks (84 days)&#xD;
Vonafexor: Oral tablets</description>
          </group>
          <group group_id="O4">
            <title>Placebo Part A</title>
            <description>Oral dose twice daily for 12 weeks (84 days)&#xD;
Placebo: Oral tablets</description>
          </group>
          <group group_id="O5">
            <title>Vonafexor Pooled Part A</title>
            <description>Oral dose once or twice a day according to treatment arms for 12 weeks (84 days)&#xD;
Vonafexor: Oral tablets</description>
          </group>
        </group_list>
        <measure>
          <title>Analysis of Percent Change (Relative) From Baseline in Percentage of Fat in the Liver as Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)</title>
          <description>The liver fat percentage was assessed by MRI-PDFF, which is an established method that enables the quantification of fat content in the liver; the value of liver fat is expressed in percentage and ranges from 0 to 100% with higher values representing higher liver fat level.</description>
          <population>For Part A, as per ICH, analysis were performed as defined in the SAP: data from the 3 vonafexor treatment groups were pooled and compared with the placebo group.&#xD;
The modified ITT (mITT) Population which was defined as patients from the ITT Population who have valid baseline and Week 12/ET MRI-PDFF measurements of LFC has been used to analyse this endpoint.</population>
          <units>Percent change</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="32"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="28"/>
                <count group_id="O4" value="5"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.5" lower_limit="-19.0" upper_limit="-2.0"/>
                    <measurement group_id="O2" value="-30.4" lower_limit="-39.4" upper_limit="-21.3"/>
                    <measurement group_id="O3" value="-25.3" lower_limit="-34.3" upper_limit="-16.2"/>
                    <measurement group_id="O4" value="11.7" lower_limit="-28.5" upper_limit="51.9"/>
                    <measurement group_id="O5" value="-25.0" lower_limit="-48.4" upper_limit="-1.5"/>
                  </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>0.0017</p_value>
            <p_value_desc>a priori threshold for statistical significance : &lt;0.05.</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.018</p_value>
            <p_value_desc>a priori threshold for statistical significance : &lt;0.05.</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.13</p_value>
            <p_value_desc>a priori threshold for statistical significance : &lt;0.05.</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Analysis of Change From Baseline in Corrected T1 (CT1)</title>
        <time_frame>12 weeks</time_frame>
        <population>For Part A, as per ICH, analysis were performed as defined in the SAP: data from the 3 vonafexor treatment groups were pooled and compared with the placebo group.&#xD;
The modified ITT (mITT) Population which was defined as patients from the ITT Population who have valid baseline and Week 12/ET MRI-PDFF measurements of LFC has been used to analyse this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Part B</title>
            <description>Oral dose once daily for 12 weeks (84 days)&#xD;
Placebo: Oral tablets</description>
          </group>
          <group group_id="O2">
            <title>Vonafexor 100 mg QD Part B</title>
            <description>Oral dose once daily for 12 weeks (84 days)&#xD;
Vonafexor: Oral tablets</description>
          </group>
          <group group_id="O3">
            <title>Vonafexor 200 mg QD Part B</title>
            <description>Oral dose once daily for 12 weeks (84 days)&#xD;
Vonafexor: Oral tablets</description>
          </group>
          <group group_id="O4">
            <title>Placebo Part A</title>
            <description>Oral dose twice daily for 12 weeks (84 days)&#xD;
Placebo: Oral tablets</description>
          </group>
          <group group_id="O5">
            <title>Vonafexor Pooled Part A</title>
            <description>Oral dose once or twice a day according to treatment arms for 12 weeks (84 days)&#xD;
Vonafexor: Oral tablets</description>
          </group>
        </group_list>
        <measure>
          <title>Analysis of Change From Baseline in Corrected T1 (CT1)</title>
          <population>For Part A, as per ICH, analysis were performed as defined in the SAP: data from the 3 vonafexor treatment groups were pooled and compared with the placebo group.&#xD;
The modified ITT (mITT) Population which was defined as patients from the ITT Population who have valid baseline and Week 12/ET MRI-PDFF measurements of LFC has been used to analyse this endpoint.</population>
          <units>msec</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="32"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="28"/>
                <count group_id="O4" value="5"/>
                <count group_id="O5" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.9" lower_limit="-38.5" upper_limit="18.7"/>
                    <measurement group_id="O2" value="-80.2" lower_limit="-110.6" upper_limit="-49.8"/>
                    <measurement group_id="O3" value="-71.8" lower_limit="-100.4" upper_limit="-43.2"/>
                    <measurement group_id="O4" value="35.0" lower_limit="-27.0" upper_limit="97.0"/>
                    <measurement group_id="O5" value="-58.2" lower_limit="-98.7" upper_limit="-17.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.001</p_value>
            <p_value_desc>a priori threshold for statistical significance : &lt;0.05.</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.002</p_value>
            <p_value_desc>a priori threshold for statistical significance : &lt;0.05.</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.018</p_value>
            <p_value_desc>a priori threshold for statistical significance : &lt;0.05.</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Analysis of Change From Baseline in Alanine Aminotransferase (ALT)</title>
        <time_frame>12 weeks</time_frame>
        <population>For Part A, as per ICH, analysis were performed as defined in the SAP: data from the 3 vonafexor treatment groups were pooled and compared with the placebo group.&#xD;
The ITT Population, defined as all patients who were randomized and administered at least 1 dose of study drug was used to analyse this endpoint but for this endpoint 1 patient in Vonafexor 200 mg QD part B arm was excluded because he experienced a serious transaminase increase due to previously undiagnosed auto-immune hepatitis.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Part B</title>
            <description>Oral dose once daily for 12 weeks (84 days)&#xD;
Placebo: Oral tablets</description>
          </group>
          <group group_id="O2">
            <title>Vonafexor 100 mg QD Part B</title>
            <description>Oral dose once daily for 12 weeks (84 days)&#xD;
Vonafexor: Oral tablets</description>
          </group>
          <group group_id="O3">
            <title>Vonafexor 200 mg QD Part B</title>
            <description>Oral dose once daily for 12 weeks (84 days)&#xD;
Vonafexor: Oral tablets</description>
          </group>
          <group group_id="O4">
            <title>Placebo Part A</title>
            <description>Oral dose twice daily for 12 weeks (84 days)&#xD;
Placebo: Oral tablets</description>
          </group>
          <group group_id="O5">
            <title>Vonafexor Pooled Part A</title>
            <description>Oral dose once or twice a day according to treatment arms for 12 weeks (84 days)&#xD;
Vonafexor: Oral tablets</description>
          </group>
        </group_list>
        <measure>
          <title>Analysis of Change From Baseline in Alanine Aminotransferase (ALT)</title>
          <population>For Part A, as per ICH, analysis were performed as defined in the SAP: data from the 3 vonafexor treatment groups were pooled and compared with the placebo group.&#xD;
The ITT Population, defined as all patients who were randomized and administered at least 1 dose of study drug was used to analyse this endpoint but for this endpoint 1 patient in Vonafexor 200 mg QD part B arm was excluded because he experienced a serious transaminase increase due to previously undiagnosed auto-immune hepatitis.</population>
          <units>U/L</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="32"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="32"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.7" lower_limit="-18.9" upper_limit="-4.6"/>
                    <measurement group_id="O2" value="-16.3" lower_limit="-24.1" upper_limit="-8.4"/>
                    <measurement group_id="O3" value="-7.5" lower_limit="-15.3" upper_limit="0.4"/>
                    <measurement group_id="O4" value="-4.1" lower_limit="-27.5" upper_limit="19.3"/>
                    <measurement group_id="O5" value="17.7" lower_limit="1.9" upper_limit="33.5"/>
                  </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>0.09</p_value>
            <p_value_desc>a priori threshold for statistical significance : &lt;0.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.47</p_value>
            <p_value_desc>a priori threshold for statistical significance : &lt;0.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.14</p_value>
            <p_value_desc>a priori threshold for statistical significance : &lt;0.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Analysis of Change From Baseline in Gamma Glutamyltranspeptidase (GT)</title>
        <time_frame>12 weeks</time_frame>
        <population>For Part A, as per ICH, analysis were performed as defined in the SAP: data from the 3 vonafexor treatment groups were pooled and compared with the placebo group.&#xD;
The Intent-to-Treat (ITT) Population, which was defined as all patients who were randomized and administered at least 1 dose of study drug was used to analyse this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Part B</title>
            <description>Oral dose once daily for 12 weeks (84 days)&#xD;
Placebo: Oral tablets</description>
          </group>
          <group group_id="O2">
            <title>Vonafexor 100 mg QD Part B</title>
            <description>Oral dose once daily for 12 weeks (84 days)&#xD;
Vonafexor: Oral tablets</description>
          </group>
          <group group_id="O3">
            <title>Vonafexor 200 mg QD Part B</title>
            <description>Oral dose once daily for 12 weeks (84 days)&#xD;
Vonafexor: Oral tablets</description>
          </group>
          <group group_id="O4">
            <title>Placebo Part A</title>
            <description>Oral dose twice daily for 12 weeks (84 days)&#xD;
Placebo: Oral tablets</description>
          </group>
          <group group_id="O5">
            <title>Vonafexor Pooled Part A</title>
            <description>Oral dose once or twice a day according to treatment arms for 12 weeks (84 days)&#xD;
Vonafexor: Oral tablets</description>
          </group>
        </group_list>
        <measure>
          <title>Analysis of Change From Baseline in Gamma Glutamyltranspeptidase (GT)</title>
          <population>For Part A, as per ICH, analysis were performed as defined in the SAP: data from the 3 vonafexor treatment groups were pooled and compared with the placebo group.&#xD;
The Intent-to-Treat (ITT) Population, which was defined as all patients who were randomized and administered at least 1 dose of study drug was used to analyse this endpoint.</population>
          <units>U/L</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="32"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="33"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.9" lower_limit="-9.9" upper_limit="2.2"/>
                    <measurement group_id="O2" value="-40.6" lower_limit="-47.1" upper_limit="-34.0"/>
                    <measurement group_id="O3" value="-34.1" lower_limit="-40.6" upper_limit="-27.7"/>
                    <measurement group_id="O4" value="3.7" lower_limit="-7.8" upper_limit="15.2"/>
                    <measurement group_id="O5" value="-25.2" lower_limit="-34.2" upper_limit="-16.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>a priori threshold for statistical significance : &lt;0.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>a priori threshold for statistical significance : &lt;0.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0002</p_value>
            <p_value_desc>a priori threshold for statistical significance : &lt;0.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Analysis of Change From Baseline in Body Weight</title>
        <time_frame>12 weeks</time_frame>
        <population>For Part A, as per ICH, analysis were performed as defined in the SAP: data from the 3 vonafexor treatment groups were pooled and compared with the placebo group.&#xD;
The Intent-to-Treat (ITT) Population, which was defined as all patients who were randomized and administered at least 1 dose of study drug was used to analyse this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Part B</title>
            <description>Oral dose once daily for 12 weeks (84 days)&#xD;
Placebo: Oral tablets</description>
          </group>
          <group group_id="O2">
            <title>Vonafexor 100 mg QD Part B</title>
            <description>Oral dose once daily for 12 weeks (84 days)&#xD;
Vonafexor: Oral tablets</description>
          </group>
          <group group_id="O3">
            <title>Vonafexor 200 mg QD Part B</title>
            <description>Oral dose once daily for 12 weeks (84 days)&#xD;
Vonafexor: Oral tablets</description>
          </group>
          <group group_id="O4">
            <title>Placebo Part A</title>
            <description>Oral dose twice daily for 12 weeks (84 days)&#xD;
Placebo: Oral tablets</description>
          </group>
          <group group_id="O5">
            <title>Vonafexor Pooled Part A</title>
            <description>Oral dose once or twice a day according to treatment arms for 12 weeks (84 days)&#xD;
Vonafexor: Oral tablets</description>
          </group>
        </group_list>
        <measure>
          <title>Analysis of Change From Baseline in Body Weight</title>
          <population>For Part A, as per ICH, analysis were performed as defined in the SAP: data from the 3 vonafexor treatment groups were pooled and compared with the placebo group.&#xD;
The Intent-to-Treat (ITT) Population, which was defined as all patients who were randomized and administered at least 1 dose of study drug was used to analyse this endpoint.</population>
          <units>kg</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="33"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" lower_limit="-1.0" upper_limit="0.9"/>
                    <measurement group_id="O2" value="-1.7" lower_limit="-2.7" upper_limit="-0.7"/>
                    <measurement group_id="O3" value="-2.5" lower_limit="-3.5" upper_limit="-1.5"/>
                    <measurement group_id="O4" value="1.2" lower_limit="-1.0" upper_limit="3.4"/>
                    <measurement group_id="O5" value="-2.2" lower_limit="-3.7" upper_limit="-0.7"/>
                  </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>0.017</p_value>
            <p_value_desc>a priori threshold for statistical significance : &lt;0.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0006</p_value>
            <p_value_desc>a priori threshold for statistical significance : &lt;0.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.006</p_value>
            <p_value_desc>a priori threshold for statistical significance : &lt;0.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Analysis of Change From Baseline in Waist Circumference</title>
        <time_frame>12 weeks</time_frame>
        <population>For Part A, as per ICH, analysis were performed as defined in the SAP: data from the 3 vonafexor treatment groups were pooled and compared with the placebo group.&#xD;
The Intent-to-Treat (ITT) Population, which was defined as all patients who were randomized and administered at least 1 dose of study drug was used to analyse this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Part B</title>
            <description>Oral dose once daily for 12 weeks (84 days)&#xD;
Placebo: Oral tablets</description>
          </group>
          <group group_id="O2">
            <title>Vonafexor 100 mg QD Part B</title>
            <description>Oral dose once daily for 12 weeks (84 days)&#xD;
Vonafexor: Oral tablets</description>
          </group>
          <group group_id="O3">
            <title>Vonafexor 200 mg QD Part B</title>
            <description>Oral dose once daily for 12 weeks (84 days)&#xD;
Vonafexor: Oral tablets</description>
          </group>
          <group group_id="O4">
            <title>Placebo Part A</title>
            <description>Oral dose twice daily for 12 weeks (84 days)&#xD;
Placebo: Oral tablets</description>
          </group>
          <group group_id="O5">
            <title>Vonafexor Pooled Part A</title>
            <description>Oral dose once or twice a day according to treatment arms for 12 weeks (84 days)&#xD;
Vonafexor: Oral tablets</description>
          </group>
        </group_list>
        <measure>
          <title>Analysis of Change From Baseline in Waist Circumference</title>
          <population>For Part A, as per ICH, analysis were performed as defined in the SAP: data from the 3 vonafexor treatment groups were pooled and compared with the placebo group.&#xD;
The Intent-to-Treat (ITT) Population, which was defined as all patients who were randomized and administered at least 1 dose of study drug was used to analyse this endpoint.</population>
          <units>cm</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="32"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="33"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" lower_limit="-1.2" upper_limit="1.3"/>
                    <measurement group_id="O2" value="-1.2" lower_limit="-2.6" upper_limit="0.1"/>
                    <measurement group_id="O3" value="-2.2" lower_limit="-3.6" upper_limit="-0.9"/>
                    <measurement group_id="O4" value="-1.8" lower_limit="-5.0" upper_limit="1.4"/>
                    <measurement group_id="O5" value="-2.9" lower_limit="-5.0" upper_limit="-0.7"/>
                  </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>0.16</p_value>
            <p_value_desc>a priori threshold for statistical significance : &lt;0.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.01</p_value>
            <p_value_desc>a priori threshold for statistical significance : &lt;0.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.57</p_value>
            <p_value_desc>a priori threshold for statistical significance : &lt;0.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Analysis of Change From Baseline in Waist to Hip ratio_Part B</title>
        <time_frame>12 weeks</time_frame>
        <population>The Intent-to-Treat (ITT) Population, which was defined as all patients who were randomized and administered at least 1 dose of study drug was used to analyse this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Part B</title>
            <description>Oral dose once daily for 12 weeks (84 days)&#xD;
Placebo: Oral tablets</description>
          </group>
          <group group_id="O2">
            <title>Vonafexor 100 mg QD Part B</title>
            <description>Oral dose once daily for 12 weeks (84 days)&#xD;
Vonafexor: Oral tablets</description>
          </group>
          <group group_id="O3">
            <title>Vonafexor 200 mg QD Part B</title>
            <description>Oral dose once daily for 12 weeks (84 days)&#xD;
Vonafexor: Oral tablets</description>
          </group>
        </group_list>
        <measure>
          <title>Analysis of Change From Baseline in Waist to Hip ratio_Part B</title>
          <population>The Intent-to-Treat (ITT) Population, which was defined as all patients who were randomized and administered at least 1 dose of study drug was used to analyse this endpoint.</population>
          <units>ratio</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.014" lower_limit="0.001" upper_limit="0.026"/>
                    <measurement group_id="O2" value="-0.017" lower_limit="-0.031" upper_limit="-0.003"/>
                    <measurement group_id="O3" value="-0.010" lower_limit="-0.024" upper_limit="0.004"/>
                  </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>0.0017</p_value>
            <p_value_desc>a priori threshold for statistical significance : &lt;0.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0093</p_value>
            <p_value_desc>a priori threshold for statistical significance : &lt;0.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Analysis of Change From Baseline in Glomerular Filtration rate_Part A</title>
        <description>For Part A, as per ICH, analysis were performed as defined in the SAP: data from the 3 vonafexor treatment groups were pooled and compared with the placebo group.</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo Part A</title>
            <description>Oral dose twice daily for 12 weeks (84 days)&#xD;
Placebo: Oral tablets</description>
          </group>
          <group group_id="O2">
            <title>Vonafexor Pooled Part A</title>
            <description>Oral dose once or twice a day according to treatment arms for 12 weeks (84 days)&#xD;
Vonafexor: Oral tablets</description>
          </group>
        </group_list>
        <measure>
          <title>Analysis of Change From Baseline in Glomerular Filtration rate_Part A</title>
          <description>For Part A, as per ICH, analysis were performed as defined in the SAP: data from the 3 vonafexor treatment groups were pooled and compared with the placebo group.</description>
          <units>mL/min/1.73m^2</units>
          <param>Geometric Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4" spread="18.4"/>
                    <measurement group_id="O2" value="-11.3" spread="12.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>After dose the first dose of study drug until D96</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Placebo Part A</title>
          <description>Oral dose twice daily for 12 weeks (84 days)&#xD;
Placebo: Oral tablets</description>
        </group>
        <group group_id="E2">
          <title>Vonafexor 100 mg BID Part A</title>
          <description>Oral dose twice daily for 12 weeks (84 days)&#xD;
Vonafexor: Oral tablets</description>
        </group>
        <group group_id="E3">
          <title>Vonafexor 200 mg QD Part A</title>
          <description>Oral dose once daily for 12 weeks (84 days)&#xD;
Vonafexor: Oral tablets</description>
        </group>
        <group group_id="E4">
          <title>Vonafexor 400 mg QD Part A</title>
          <description>Oral dose once daily for 12 weeks (84 days)&#xD;
Vonafexor: Oral tablets</description>
        </group>
        <group group_id="E5">
          <title>Placebo Part B</title>
          <description>Oral dose once daily for 12 weeks (84 days)&#xD;
Placebo: Oral tablets</description>
        </group>
        <group group_id="E6">
          <title>Vonafexor 100 mg QD Part B</title>
          <description>Oral dose once daily for 12 weeks (84 days)&#xD;
Vonafexor: Oral tablets</description>
        </group>
        <group group_id="E7">
          <title>Vonafexor 200 mg QD Part B</title>
          <description>Oral dose once daily for 12 weeks (84 days)&#xD;
Vonafexor: Oral tablets</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (22.0)</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="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina instable</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="5"/>
                <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="32"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="5"/>
                <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="32"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="5"/>
                <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="32"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="5"/>
                <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="32"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="5"/>
                <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="32"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (22.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="22" subjects_at_risk="32"/>
                <counts group_id="E6" subjects_affected="25" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="30" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="5"/>
                <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="32"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="5"/>
                <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="32"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="5"/>
                <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="32"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="5"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="5" subjects_affected="5" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="5"/>
                <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="32"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="5"/>
                <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="32"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="2" subjects_affected="1" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Abdominal rigidity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="5"/>
                <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="32"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="5"/>
                <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="32"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="5"/>
                <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="32"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E7" events="5" subjects_affected="4" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="5"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="5"/>
                <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="32"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Adverse drug reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="5"/>
                <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="32"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="5"/>
                <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="32"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatic cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="5"/>
                <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="32"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="5"/>
                <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="32"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="5"/>
                <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="32"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="5"/>
                <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="32"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E7" events="2" subjects_affected="1" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Skin abrasion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="5"/>
                <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="32"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Electric shock</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="5"/>
                <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="32"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Foot fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="5"/>
                <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="32"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Post-traumatic pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="5"/>
                <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="32"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="5"/>
                <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="32"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="3" subjects_affected="3" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Low density lipoprotein increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="5"/>
                <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="32"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="5"/>
                <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="32"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="5"/>
                <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="32"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetes mellitus inadequate control</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="5"/>
                <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="32"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Type 2 diabetes mellitus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="5"/>
                <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="32"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Hypercholesterolaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="5"/>
                <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="32"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="4" subjects_affected="3" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Hyperlipidaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="5"/>
                <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="32"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Squamous cell carcinoma of skin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="5"/>
                <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="32"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="5"/>
                <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="32"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="5"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="6" subjects_affected="4" subjects_at_risk="32"/>
                <counts group_id="E6" events="4" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="5"/>
                <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="32"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="5"/>
                <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="32"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="5"/>
                <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="32"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="5"/>
                <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="32"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="3" subjects_affected="2" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="5"/>
                <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="32"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Renal cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="5"/>
                <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="32"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="5"/>
                <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="32"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="7" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="5"/>
                <counts group_id="E4" events="10" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="32"/>
                <counts group_id="E6" events="29" subjects_affected="19" subjects_at_risk="31"/>
                <counts group_id="E7" events="36" subjects_affected="22" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="5"/>
                <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="32"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Rash macular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="5"/>
                <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="32"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Rash pruritic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="5"/>
                <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="32"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Skin lesion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="5"/>
                <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="32"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="5"/>
                <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="32"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The data may be considered for publication in a scientific journal or for reporting at a scientific meeting. Each Investigator is obligated to keep data pertaining to the study confidential. The Investigator must consult with the Sponsor before any study data are submitted for publication. The Sponsor reserves the right to deny publication rights until mutual agreement on the content, format, interpretation of data in the manuscript, and journal selected for publication are achieved.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Pietro Scalfaro</name_or_title>
      <organization>ENYO Pharma SA</organization>
      <phone>+33437700219</phone>
      <email>ps@enyopharma.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/NCT03812029
org study id: EYP001-202
secondary id: 2018-003119-22
nct id: NCT03812029
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to assess the effects of EYP001a (Vonafexor) with respect to
      safety, tolerability, pharmacokinetics and on markers of liver inflammation in patients with
      NASH
This is a 2-part, randomized, double-blind, multicenter, placebo-controlled study to evaluate
      the safety and efficacy of Vonafexor in patients with NASH who likely have stage F2 to F3
      fibrosis at approximately 50 global clinical sites. Overall, approximately 114 eligible
      patients will be enrolled: 24 patients in Part A (Safety Run-in Cohort), followed by 90
      patients in Part B.

      In Part A, 24 patients will be randomized on Day 1 to 1 of 4 parallel treatment groups: 100
      mg Vonafexor twice daily (BID), 200 mg Vonafexor once daily (QD), 400 mg Vonafexor QD, or
      placebo BID. In Part B, 90 patients will be randomized on Day 1 to 1 of 3 parallel treatment
      groups: 100 mg Vonafexor QD, 200 mg Vonafexor QD, or placebo QD.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Parallel assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
masking description: Triple (Participant, Care Provider, Investigator)
measure: Analysis of Absolute Change From Baseline in Percentage of Fat in the Liver as Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)
time frame: 12 weeks
description: The liver fat percentage was assessed by MRI-PDFF, which is an established method that enables the quantification of fat content in the liver; the value of liver fat is expressed in percentage and ranges from 0 to 100% with higher values representing higher liver fat level.
measure: Analysis of Change From Baseline in Glomerular Filtration rate_Part B
time frame: 12 weeks
measure: Analysis of Percent Change (Relative) From Baseline in Percentage of Fat in the Liver as Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)
time frame: 12 weeks
description: The liver fat percentage was assessed by MRI-PDFF, which is an established method that enables the quantification of fat content in the liver; the value of liver fat is expressed in percentage and ranges from 0 to 100% with higher values representing higher liver fat level.
measure: Analysis of Change From Baseline in Corrected T1 (CT1)
time frame: 12 weeks
measure: Analysis of Change From Baseline in Alanine Aminotransferase (ALT)
time frame: 12 weeks
measure: Analysis of Change From Baseline in Gamma Glutamyltranspeptidase (GT)
time frame: 12 weeks
measure: Analysis of Change From Baseline in Body Weight
time frame: 12 weeks
measure: Analysis of Change From Baseline in Waist Circumference
time frame: 12 weeks
measure: Analysis of Change From Baseline in Waist to Hip ratio_Part B
time frame: 12 weeks
measure: Analysis of Change From Baseline in Glomerular Filtration rate_Part A
time frame: 12 weeks
description: For Part A, as per ICH, analysis were performed as defined in the SAP: data from the 3 vonafexor treatment groups were pooled and compared with the placebo group.
arm group label: Vonafexor 100 mg BID
arm group type: Experimental
description: Oral dose twice daily for 12 weeks (84 days)
arm group label: Vonafexor 200 mg QD
arm group type: Experimental
description: Oral dose once daily for 12 weeks (84 days)
arm group label: Vonafexor 400 mg QD
arm group type: Experimental
description: Oral dose once daily for 12 weeks (84 days)
arm group label: Placebo
arm group type: Placebo Comparator
description: Oral dose twice daily for 12 weeks (84 days)
arm group label: Vonafexor 100 mg QD
arm group type: Experimental
description: Oral dose once daily for 12 weeks (84 days)
intervention type: Drug
intervention name: Vonafexor
description: Oral tablets
arm group label: Vonafexor 100 mg BID
arm group label: Vonafexor 100 mg QD
arm group label: Vonafexor 200 mg QD
arm group label: Vonafexor 400 mg QD
intervention type: Other
intervention name: Placebo
description: Oral tablets
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Harrison Stephen, MD
role: Principal Investigator
affiliation: Pinnacle Clinical Research
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country: Belgium
country: France
country: Puerto Rico
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Fatty Liver
mesh term: Non-alcoholic Fatty Liver Disease
provided document: 
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