<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/NCT01694849</url>
  </required_header>
  <id_info>
    <org_study_id>GFT505-212-7</org_study_id>
    <secondary_id>2012-000295-42</secondary_id>
    <nct_id>NCT01694849</nct_id>
  </id_info>
  <brief_title>Phase IIb Study to Evaluate the Efficacy and Safety of GFT505 Versus Placebo in Patients With Non-Alcoholic Steatohepatitis (NASH)</brief_title>
  <official_title>A Multicentre, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GFT505 Once Daily on Steatohepatitis in Patients With Non-Alcoholic Steatohepatitis (NASH).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Genfit</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Naturalpha</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Premier Research Group plc</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Genfit</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Abdominal obesity and type-2 Diabetes are associated with chronic liver disorders resulting&#xD;
      from the accumulation of fat in the liver (steatosis), which may progress towards hepatitis&#xD;
      and possibly lead to cirrhosis and liver cancer. NAFLD (Non Alcoholic Fatty Liver Disease) is&#xD;
      considered as the most common form of chronic liver disease in adults in the United States,&#xD;
      Australia, Asia and Europe. In the USA, the estimated prevalence of NAFLD is 20-30% of the&#xD;
      adult population.&#xD;
&#xD;
      Non-alcoholic Steatohepatitis (NASH) is a progressing form of NAFLD, which corresponds to&#xD;
      hepatic steatosis associated with inflammation and liver cell injury upon microscopic&#xD;
      examination of a liver biopsy. This condition may lead to advanced fibrosis and cirrhosis and&#xD;
      deserves serious medical management. Up to now, there is no effective drug which has clearly&#xD;
      demonstrated therapeutic efficacy which may help lifestyle and dietary recommendations in the&#xD;
      resolution of NASH.&#xD;
&#xD;
      In this context, GENFIT is developing a new liver targeted drug candidate, GFT505, for the&#xD;
      treatment of NASH and the reduction of multiple cardiometabolic risk factors associated with&#xD;
      the metabolic syndrome and type 2 Diabetes.&#xD;
&#xD;
      This phase IIb study will evaluate the efficacy and safety of GFT505 80mg and 120mg once&#xD;
      daily for 52 weeks on the reversal of NASH without worsening of fibrosis, based on liver&#xD;
      biopsy assessments.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study duration per patient will be 80 weeks. A screening period (from 4 to 16 weeks) will&#xD;
      precede a 52-week double-blind treatment period and a 3 months follow-up period.&#xD;
&#xD;
      The study will be conducted in 270 patients (90 patients in the placebo arm, 90 patients in&#xD;
      the GFT505 80mg arm, and 90 patients in the GFT505 120mg arm).&#xD;
&#xD;
      Enrollment will be performed in two phases: during the first phase, the patients will receive&#xD;
      either GFT505 at a dose of 80 mg either the placebo. An independent expert committee will&#xD;
      review the safety data when 45 patients receiving the dose at 80 mg will have been treated&#xD;
      for 6 months. The committee approval will be necessary to start the second phase, while the&#xD;
      patients will receive either GFT505 at a dose of 80 mg, or GFT505 at a dose of 120 mg or the&#xD;
      placebo.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Responders With Disappearance of Steatohepatitis Without Worsening of Fibrosis (ie, Participants no Longer Meeting the Criteria for Steatohepatitis)</measure>
    <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
    <description>Percentage of responders from baseline to Week 52 defined by the disappearance of steatohepatitis (ie, participants no longer meeting the criteria for steatohepatitis) without worsening of fibrosis.&#xD;
Worsening of fibrosis was evaluated using Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) fibrosis staging system and defined as:&#xD;
Progression to stage 3 or 4 for participants at stage 0, 1 or 2 on diagnostic liver biopsy&#xD;
Progression to stage 4 for participants at stage 3 on diagnostic liver biopsy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 52 in Non-alcoholic Fatty Liver Disease Activity Score</measure>
    <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
    <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg the change from baseline to Week 52, in Non-alcoholic Fatty Liver Disease Activity Score (NAS score).&#xD;
NAS score is a composite score equal to the sum of the steatosis grade (0 to 3), lobular inflammation grade (0 to 3) and hepatocellular ballooning grade (0 to 2). The overall scale of the NAS is 0 to 8, with higher scores indicating more severe disease. The outcome measure, change from baseline in NAFLD Activity Score (NAS), has a possible range from -8 to +8, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Change From Baseline to Week 52 in Non-alcoholic Fatty Liver Disease Activity Score of at Least 2 Points</measure>
    <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
    <description>To evaluate the number of participants with at least a 2 point decrease from baseline in Non-alcoholic Fatty Liver Disease Activity Score (NAS) after 52 weeks of daily administration of GFT505 80mg or 120mg. The NAS refers to the severity of ongoing liver injury as assessed by a liver biopsy and is used to assess the activity of the disease. It is based on the NASH CRN methodology for scoring the severity of steatosis (score of 0 to 3), inflammation (score of 0 to 3), and hepatocellular ballooning (score of 0 to 2), with a maximum score of 8. A total NAS score of five or greater correlates with the diagnosis of steatohepatitis.&#xD;
In table below for raw &quot;Mild (Nonalcoholic Fatty Liver Disease Activity Score 3)&quot; and the column &quot;GFT505 80mg&quot; the result should be read as : 2 participants (out of 10 participants analysed with a baseline NAS at 3) had at Least 2 points decrease on their NAS after 52 weeks of daily administration of GFT505 80mg. It corresponds to 20% (2 out of 10).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Decrease in Steatosis Score of at Least 1 Point Between Baseline and Week 52</measure>
    <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
    <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, number of participants with a decrease in steatosis score of at least 1 point between baseline and Week 52.&#xD;
Steatosis is assessed by a liver biopsy and evaluated on a scale of 0 to 3 with higher scores indicating more severe steatosis. A score of 0 indicating a lower severity with low parenchymal involvement (&lt;5%), while a score of 3 is indicative of higher involvment/severity (&gt; 66%).&#xD;
In below table and for helping how results are reported, as an example for raw &quot;Mild (Nonalcoholic Fatty Liver Disease Activity Score 3)&quot; and the column &quot;GFT505 80mg&quot; the result should be read as : 1 participants (out of 10 participants analysed with a baseline NAS at 3) had at least 1 point decrease Steatosis Score after 52 weeks of daily administration of GFT505 80mg. It corresponds to 10% (1 out of 10).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Decrease in Lobular Inflammation Score of at Least 1 Point Between Baseline and Week 52</measure>
    <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
    <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, number of participants with a decrease in lobular inflammation score of at least 1 point between baseline and Week 52.&#xD;
Lobular inflammation is assessed by a liver biopsy and evaluated on a scale of 0 to 3. A score of 0 indicating the absence of inflammation loci, while a score of 3 is indicative of a higher degree of inflammation with more than 4 inflammation loci 200 x field.&#xD;
In below table and for helping how results are reported, as an example for raw &quot;Mild (Nonalcoholic Fatty Liver Disease Activity Score 3)&quot; and the column &quot;GFT505 80mg&quot; the result should be read as : 1 participants (out of 10 participants analysed with a baseline NAS at 3) had at least 1 point decrease of Lobular Inflammation Score after 52 weeks of daily administration of GFT505 80mg. It corresponds to 10% (1 out of 10).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Title: Number of Participants With Decrease in Ballooning Score of at Least 1 Point Between Baseline and Week 52</measure>
    <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
    <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, number of participants with a decrease in ballooning score of at least 1 point between baseline and Week 52.&#xD;
Ballooning is assessed by a liver biopsy and evaluated on a scale of 0 to 2 with higher scores indicating more severe ballooning (0: No ballooned cells, 1: Few [rare but definite] ballooned hepatocytes; 2: Many ballooned cells/prominent ballooning).&#xD;
In below table and for helping how results are reported, as an example for raw &quot;Mild (Nonalcoholic Fatty Liver Disease Activity Score 3)&quot; and the column &quot;GFT505 80mg&quot; the result should be read as : 4 participants (out of 10 participants analysed with a baseline NAS at 3) had at least 1 point decrease of Ballooning Score after 52 weeks of daily administration of GFT505 80mg. It corresponds to 10% (1 out of 10).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes From Baseline to Week 52 in the Stages of Fibrosis</measure>
    <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
    <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in stages of fibrosis (based on Non-Alcoholic Steatohepatitis Clinical Research Network [NASH CRN] scoring).&#xD;
Fibrosis is assessed on a scale of 0 to 4 with higher scores indicating more severe fibrosis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes From Baseline to Visit 8 (Week 52) in Liver Enzymes</measure>
    <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
    <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to week 52, in liver enzymes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes From Baseline to Visit 8 (Week 52) in Aspartate Transaminase/Alanine Aminotransferase Ratio</measure>
    <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
    <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to week 52, in aspartate transaminase/alanine aminotransferase ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: CK 18-M65</measure>
    <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
    <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in CK 18-M65 (non-invasive markers of fibrosis and steatosis).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: CK18 M30</measure>
    <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
    <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in CK18 M30 (non-invasive markers of fibrosis and steatosis).&#xD;
Participants with missing data for CK18 M30 at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the &quot;Efficacy Evaluable Set&quot; of the Participant Flow.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Adiponectin</measure>
    <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
    <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in adiponectin (non-invasive markers of fibrosis and steatosis).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Ferritin</measure>
    <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
    <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in ferritin (non-invasive markers of fibrosis and steatosis).&#xD;
Participants with missing data for Ferritin at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the &quot;Efficacy Evaluable Set&quot; of the Participant Flow.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: FG19 and FG21</measure>
    <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
    <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in FG19 and FG21 (non-invasive markers of fibrosis and steatosis).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Alpha2 Macroglobulin</measure>
    <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
    <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in alpha2 macroglobulin (a non-invasive marker of fibrosis and steatosis).&#xD;
Participants with missing data for Alpha2 Macroglobulin at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the &quot;Efficacy Evaluable Set&quot; of the Participant Flow.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Hyaluronic Acid, N-terminal Pro-peptide of Collagen Type III (PIIINP), and Tissue Inhibitor of Matrix Metalloprotease-1 (TIMP-1)</measure>
    <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
    <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in hyaluronic acid, N-terminal pro-peptide of collagen type III (PIIINP), and tissue inhibitor of matrix metalloprotease-1 (TIMP-1) (non-invasive markers of fibrosis and steatosis).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Fibrotest</measure>
    <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
    <description>Fibrotest combines α2-macroglobulin (a2m), apolipoprotein A1 (aA1), total bilirubin (BIL), haptoglobin (h), GGT, and ALT with adjustment for age and gender. Fibrotest is calculated as: z = 4.467 x log(a2m) - 1.357 x log(h) + 1.017 x log(GGT) + 0.0281 x Age + 1.737 x log(BIL) - 1.184 x (aA1) + 0.301 x Gender - 5.54 where Gender = 1 for male and Gender = 0 for female. The score is then: 1/(1+e^-z). Calculated score range from 0 (no fibrosis) to 1 (severe fibrosis or cirrhosis) In below table for &quot;Fibrotest&quot; and for column &quot;GFT505 80mg&quot; the result should be read as: the mean of change from baseline to week 52 of Fibrotest calculated in 81 participants is -0.06 with a standard deviation of 0.08.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Steatotest</measure>
    <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
    <description>SteatoTest combines α2-macroglobulin, haptoglobin, apolipoprotein A1, total bilirubin, GGT, fasting glucose, triglycerides, cholesterol, and ALT, adjusted for patient's age, sex, weight, and height. Patented formula. Calculated score range from 0 (no steatosis) to 1 (severe steatosis) In below table for &quot;Steatotest&quot; and for column &quot;GFT505 80mg&quot; the result should be read as: the mean of change from baseline to week 52 of Steatotest calculated in 81 participants is -0.09 with a standard deviation of 0.11.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Angulo Index or Non-Alcoholic Fatty Liver Disease Fibrosis Score</measure>
    <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
    <description>Angulo Index or Non-Alcoholic Fatty Liver Disease Fibrosis Score is based on age, hyperglycemia, BMI, platelet count, albumin level, and AST/ALT ratio. Score is calculated using the following formula: -1.675 + 0.037 × age (years) + 0.094 × BMI (kg/m^2) + 1.13 × IFG/diabetes (yes = 1, no = 0) + 0.99 × AST/ALT ratio - 0.013 × platelet (×10^9/l) - 0.66 × albumin (g/dl). A score of &lt;-1.455 indicates no advanced fibrosis and a score of &gt;0.676 indicates liver fibrosis.&#xD;
In below table for &quot;Angulo index&quot; and for column &quot;GFT505 80mg&quot; the result should be read as: the mean of change from baseline to week 52 of Angulo index calculated in 82 participants is 0.06 with a standard deviation of 0.53.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Enhanced Liver Fibrosis (ELF)</measure>
    <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
    <description>Enhanced Liver Fibrosis (ELF) combines measurements of tissue inhibitor of metalloprotein-ases-1 (TIMP-1), amino-terminal propeptide of type III procollagen (PIIINP), and hyaluronic acid (HA) . The ELF score is calculated as : 2.278 + 0.851 ln (HA) + 0.751 ln (PIIINP) + 0.394 ln (TIMP-1). ELF score range from An ELF score of less than 7.7 indicates no fibrosis. An ELF score greater than or equal to 9.8 indicates severe fibrosis. An ELF score of 11.3 or greater indicates cirrhosis. A decrease in ELF score represents a positive outcome In below table for &quot;Enhanced Liver Fibrosis&quot; and for column &quot;GFT505 80mg&quot; the result should be read as : the mean of change from baseline to week 52 of Enhanced Liver Fibrosis calculated in 81 analysed participants is -0.01 with a standard deviation of 0.54.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Fatty Liver Index (FLI)</measure>
    <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
    <description>The Fatty Liver Index (FLI) combines triglycerides, BMI, GGT and Waist circumference. FLI is calculated as : (e0.953×loge[triglycerides]+0.139× Body Mass Index[BMI]+0.718×loge Gamma- Glutamyl Transferase [GGT]+0.053×waistcircumference-15.745)/ (1 +e0.953×loge[triglycerides]+0.139×BMI+0.718×loge [GGT]+0.053×waistcircumference-15.745) × 100. Calculated index range from 0 to 100. FLI score below 30 indicate absence of Fatty Liver and FLI Score of 60 and above indicates presence of Fatty Liver.&#xD;
In below table for &quot;Fatty Liver Index&quot; and for column &quot;GFT505 80mg&quot; the result should be read as : the mean of change from baseline to week 52 of Fatty Liver Index calculated in 82 analysed participants is -7.94 with a standard deviation of 11.74.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Fibrometer</measure>
    <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
    <description>Fibrometer combines Platelets, AST, ALT, ferritin, glucose (fasting plasma), Weight and gender. Patented formula. Score ranges from 0 (no fibrosis) to 1 (severe fibrosis or cirrhosis) In below table for &quot;Fibrometer&quot; and for column &quot;GFT505 80mg&quot; the result should be read as : the mean of change from baseline to week 52 of Fibrometer calculated in 81 analysed participants is 0.04 with a standard deviation of 0.23.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Total Bilirubin and Conjugated Bilirubin</measure>
    <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
    <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in total bilirubin and conjugated bilirubin (non-invasive markers of fibrosis and steatosis).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Prothrombin Ratio</measure>
    <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
    <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in prothrombin ratio (non-invasive marker of fibrosis and steatosis).&#xD;
The Prothrombin ratio is the ratio of a participants measured prothrombin time (in seconds) to the normal laboratory reference prothrombin time.&#xD;
Participants with missing data for Prothrombin ratio at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the &quot;Efficacy Evaluable Set&quot; of the Participant Flow.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: International Normalized Ratio (INR)</measure>
    <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
    <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in international normalized ratio (INR; non-invasive marker of fibrosis and steatosis).&#xD;
Participants with missing data for International Normalized Ratio (INR) at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the &quot;Efficacy Evaluable Set&quot; of the Participant Flow.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes From Baseline to Week 52 in Lipid Parameters (Cardiovascular Risk Profile)</measure>
    <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
    <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to week 52, in lipid parameters (used to assess cardiovascular risk)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes From Baseline to Week 52 in Outcomes Related to Biochemistry</measure>
    <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
    <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to week 52, in secondary outcomes related to biochemistry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes From Baseline to Week 52 in Insulin Resistance: Leptin</measure>
    <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
    <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in leptin (to assess insulin resistance).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes From Baseline to Week 52 in Insulin Resistance: Insulin</measure>
    <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
    <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in insulin (to assess insulin resistance).&#xD;
Participants with missing data for Insulin at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the &quot;Efficacy Evaluable Set&quot; of the Participant Flow.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes From Baseline to Week 52 in Insulin Resistance: C Peptide</measure>
    <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
    <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in C peptide (to assess insulin resistance).&#xD;
Participants with missing data for C Peptide at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the &quot;Efficacy Evaluable Set&quot; of the Participant Flow.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes From Baseline to Week 52 in Insulin Resistance: Homeostatic Model Assessment-insulin Resistance (HOMA-IR)</measure>
    <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
    <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in homeostatic model assessment-insulin resistance (HOMA-IR; to assess insulin resistance).&#xD;
The HOMA-IR is expressed as the following: HOMA-IR = fasting serum insulin (μU/ml) x fasting plasma glucose (mmol/l) / 22.5&#xD;
A decrease in HOMA-IR indicates a positive outcome. HOMA-IR values of greater than 1.9 indicates early insulin resistance and levels above 2.9 indicate significant insulin resistance.&#xD;
Participants with missing data for HOMA-IR at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the &quot;Efficacy Evaluable Set&quot; of the Participant Flow.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes From Baseline to Week 52 in Insulin Resistance: Free Fatty Acids (FFA)</measure>
    <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
    <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in free fatty acids (FFA; to assess insulin resistance).&#xD;
Participants with missing data for Free Fatty Acids (FFA) at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the &quot;Efficacy Evaluable Set&quot; of the Participant Flow.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes From Baseline to Week 52 in Insulin Resistance: Plasma Glucose</measure>
    <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
    <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in plasma glucose (to assess insulin resistance).&#xD;
Participants with missing data for Plasma Glucose at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the &quot;Efficacy Evaluable Set&quot; of the Participant Flow.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes From Baseline to Week 52 in Insulin Resistance: Glycosylated Haemoglobin A1c (HbA1c)</measure>
    <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
    <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in glycosylated haemoglobin A1c (HbA1c; to assess insulin resistance).&#xD;
Participants with missing data for Haemoglobin A1c (HbA1c) at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the &quot;Efficacy Evaluable Set&quot; of the Participant Flow.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes From Baseline to Week 52 in Insulin Resistance: Fructosamine</measure>
    <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
    <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in Fructosamine (to assess insulin resistance).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes From Baseline to Week 52 in Inflammatory Markers: Fibrinogen and Haptoglobin</measure>
    <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
    <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to Week 52, in fibrinogen and haptoglobin (inflammatory markers).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes From Baseline to Week 52 in Inflammatory Markers: Tumour Necrosis Factor Alpha and Interleukine 6</measure>
    <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
    <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to Week 52, in tumour necrosis factor alpha and interleukine 6 (inflammatory markers).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes From Baseline to Week 52 in Inflammatory Markers: Plasminogen Activator Inhibitor 1 (PAI-1)</measure>
    <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
    <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to Week 52, in plasminogen activator inhibitor 1 (PAI-1; inflammatory marker).&#xD;
Participants with missing data for Plasminogen Activator Inhibitor 1 (PAI-1) at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the &quot;Efficacy Evaluable Set&quot; of the Participant Flow</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes From Baseline to Week 52 in Inflammatory Markers: C-Reactive Protein (CRP)</measure>
    <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
    <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to Week 52, in C-Reactive Protein (CRP; inflammatory marker).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes From Baseline to Week 52 in Safety Markers: Creatinine (Renal Function Parameter)</measure>
    <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
    <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in creatinine (safety markers; renal function parameter).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes From Baseline to Week 52 in Safety Markers: Creatinine Clearance (Renal Function Parameter)</measure>
    <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
    <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in creatinine clearance (safety marker; renal function parameter).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes From Baseline to Week 52 in Safety Markers: Uric Acid (Renal Function Parameter)</measure>
    <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
    <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in uric acid (safety marker; renal function parameter).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes From Baseline to Week 52 in Safety Markers: Blood Urea Nitrogen (BUN; Renal Function Parameter)</measure>
    <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
    <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in blood urea nitrogen (BUN; safety marker; renal function parameter).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes From Baseline to Week 52 in Safety Markers: Cystatin C (Renal Function Parameter)</measure>
    <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
    <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in cystatin C (safety marker; renal function parameter).&#xD;
Participants with missing data for Cystatin C at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the &quot;Efficacy Evaluable Set&quot; of the Participant Flow.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes From Baseline to Week 52 in Safety Markers: Beta2-microglobulin (Renal Function Parameter)</measure>
    <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
    <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in beta2-microglobulin (safety marker; renal function parameter).&#xD;
Participants with missing data for Beta2-microglobulin at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the &quot;Efficacy Evaluable Set&quot; of the Participant Flow.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes From Baseline to Week 52 in Safety Markers: N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP; Cardiac Function Parameter)</measure>
    <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
    <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in N-terminal prohormone of brain natriuretic peptide (NT-proBNP; safety marker; cardiac function parameter).&#xD;
Participants with missing data for NT-proBNP at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the &quot;Efficacy Evaluable Set&quot; of the Participant Flow.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes From Baseline to Week 52 in Safety Markers: Troponin T (Cardiac Function Parameter)</measure>
    <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
    <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in troponin T (safety marker; cardiac function parameter).&#xD;
Participants with missing data for Troponin T at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the &quot;Efficacy Evaluable Set&quot; of the Participant Flow.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes From Baseline to Week 52 in Body Weight</measure>
    <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
    <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in body weight.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">275</enrollment>
  <condition>Non-Alcoholic Steatohepatitis (NASH)</condition>
  <arm_group>
    <arm_group_label>GFT505 80mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hard gelatin capsules dosed at 40mg, oral administration, 3 capsules per day before breakfast with a glass of water.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GFT505 120mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hard gelatin capsules dosed at 40mg, oral administration, 3 capsules per day before breakfast with a glass of water.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>hard gelatin capsules, oral administration, 3 capsules per day before breakfast with a glass of water.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GFT505 80mg</intervention_name>
    <arm_group_label>GFT505 80mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GFT505 120mg</intervention_name>
    <arm_group_label>GFT505 120mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males or females (females must be either of non-child bearing potential or using an&#xD;
             efficient double contraception). For male participants, contraceptive measures must be&#xD;
             taken during the study, either by the male participant or his female partner.&#xD;
&#xD;
          -  Body Mass Index ≤ 45 kg/m².&#xD;
&#xD;
          -  Patients agree to have one liver biopsy during the screening period for diagnostic&#xD;
             purpose (if no historical biopsy within 6 months before randomization is available)&#xD;
             and one at the end of the treatment period for assessment of the treatment effects.&#xD;
&#xD;
          -  For hypertensive patients, hypertension must be controlled by stable dose of&#xD;
             anti-hypertensive medication for at least 2 months prior to screening (and the stable&#xD;
             dose can be maintained throughout the study).&#xD;
&#xD;
          -  Patients treated with vitamin E (&gt;400IU/d), or Polyunsaturated fatty acids (&gt;2g/day)or&#xD;
             Ursodeoxycholic acid can be included if drugs are stopped at least 3 months prior to&#xD;
             diagnostic liver biopsy and up to the end of the study.&#xD;
&#xD;
          -  Histological confirmation of steatohepatitis on a diagnostic liver biopsy.&#xD;
             Histological diagnostic is confirmed by central reading of the slides (steatosis &gt; 5%&#xD;
             + lobular inflammation, any grade + ballooning, any amount).&#xD;
&#xD;
          -  For patients with Type 2 Diabetes, glycemia must be controlled (Glycosylated&#xD;
             Haemoglobin A1c ≤8.5%). If glycemia is controlled by anti-diabetic drugs, qualitative&#xD;
             change is not permitted within 6 months prior to randomization and should be avoided&#xD;
             during the study. Treatments with metformin, Dipeptidyl Peptidase 4 inhibitors,&#xD;
             Glucagon-like peptide-1 agonists, sulfamides, insulin are authorized. Sulfamides and&#xD;
             insulin are permitted if glycemia is self-monitored by the patient.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known heart failure (Grade I to IV of New York Heart Association classification).&#xD;
&#xD;
          -  Weight loss of more than 5% within 6 months prior to randomization.&#xD;
&#xD;
          -  History of bariatric surgery.&#xD;
&#xD;
          -  Uncontrolled Blood Pressure.&#xD;
&#xD;
          -  Type 1 diabetes patients.&#xD;
&#xD;
          -  Patients who had an acute cardiovascular episode within the 6 months prior to&#xD;
             screening, or with a history of coronary angioplasty, history of stroke, Transient&#xD;
             Ischemic Attack, Coronary Heart Disease.&#xD;
&#xD;
          -  Compensated and uncompensated cirrhosis. Notably, NASH patients with fibrosis stage =&#xD;
             4 according to the NASH CRN fibrosis staging system are excluded.&#xD;
&#xD;
          -  Known alcohol and/or any other drug abuse or dependence in the last five years.&#xD;
&#xD;
          -  Pregnant or lactating females.&#xD;
&#xD;
          -  Other well documented causes of chronic liver disease&#xD;
&#xD;
          -  Known intolerance or contra-indication to the list of excipients of GFT505.&#xD;
&#xD;
          -  Evidence of any other unstable or, untreated clinically significant immunological,&#xD;
             neoplastic, endocrine, haematological, gastrointestinal, neurological or psychiatric&#xD;
             disorder.&#xD;
&#xD;
          -  Positive HBsAg (Hepatitis B Surface Antigen), Positive anti-HIV, positive HCV-RNA&#xD;
             (Hepatitis C Virus).&#xD;
&#xD;
          -  Uncontrolled hypothyroidism defined as Thyroid Stimulating Hormone &gt; 2X the upper&#xD;
             limit of normal (ULN). Thyroid dysfunction controlled for at least 6 months prior to&#xD;
             screening is permitted.&#xD;
&#xD;
          -  Significant renal disease, including nephritic syndrome, chronic renal failure&#xD;
             (defined as creatinine clearance &lt; 60 mL/mn and serum creatinine &gt;180 μmol/L).&#xD;
&#xD;
          -  Unexplained serum creatine phosphokinase (CPK) &gt; 3X the upper limit of normal (ULN).&#xD;
             Patients with a reason for CPK elevation may have the measurement repeated prior to&#xD;
             randomization; a CPK retest &gt; 3X ULN leads to exclusion.&#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>Rémy HANF, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Development Director Genfit, France</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pr. Vlad RATZIU, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>International Coordinator - La Pitié-Salpêtrière Hospital - Paris 13, France</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pr. Arun SANYAL, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Coordinator -Virginia Commonwealth University - Richmond - USA</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dr. Sven FRANCQUE, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Coordinator - UZA - Edegem - Belgium</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dr. Jost PH DRENTH, MD, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Coordinator - UMC St Radboud Nijmegen - Nijmegen - The Netherlands</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pr. Michael Manns, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Coordinator - Medical School of Hannover - Hannover - Germany</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pr. Elisabetha BUGIANESI, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Coordinator - University of Torino - S. Giovanni Battista Hospital - Torino - Italy</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pr. Mihai VOICULESCU, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Coordinator - Center of Internal Medicine, Fundeni Clinical Institute - Bucharest - Romania</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pr. Manuel ROMERO-GOMEZ, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Coordinator - Valme University hospital - Sevilla - Spain</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pr. Quentin M. ANSTEE, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Coordinator - Freeman Hospital - Newcastle - UK</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Site 920</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>CA 9372</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 903</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>CA 92037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 911</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>CO 80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 912</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>FL 32610-0277</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 924</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>GA 30303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 917</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>GA 30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 909</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>LA 70112-2600</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 921</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>MA 01655</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 902</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>MI 48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 927</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>NY 10029-6574</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 908</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>NC 27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 919</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>PA 19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 916</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>TN 38104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 913</name>
      <address>
        <city>Fort Sam Houston</city>
        <state>Texas</state>
        <zip>TX 78234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 923</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>TX 77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 906</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>TX 78215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 931</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>UT 84132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 930</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>VA 22908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 901</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>VA 23298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 205</name>
      <address>
        <city>Brussels</city>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 201</name>
      <address>
        <city>Edegem</city>
        <zip>B-2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 204</name>
      <address>
        <city>Gent</city>
        <zip>B-9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 202</name>
      <address>
        <city>Haine-Saint-Paul</city>
        <zip>7100</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 203</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 106</name>
      <address>
        <city>Amiens</city>
        <zip>80054</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 102</name>
      <address>
        <city>Angers</city>
        <zip>49933</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 114</name>
      <address>
        <city>Clichy</city>
        <zip>92110</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 103</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 113</name>
      <address>
        <city>Lyon</city>
        <zip>69317</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 111</name>
      <address>
        <city>Marseille</city>
        <zip>13285</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 108</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 104</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 109</name>
      <address>
        <city>Nice</city>
        <zip>06202</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 112</name>
      <address>
        <city>Paris</city>
        <zip>75571</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 101</name>
      <address>
        <city>Paris</city>
        <zip>75651</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 107</name>
      <address>
        <city>Pessac</city>
        <zip>33604</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 405</name>
      <address>
        <city>Bonn</city>
        <zip>53127</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 404</name>
      <address>
        <city>Mainz</city>
        <zip>55131</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 507</name>
      <address>
        <city>Milano</city>
        <zip>20122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 503</name>
      <address>
        <city>Palermo</city>
        <zip>90127</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 504</name>
      <address>
        <city>Roma</city>
        <zip>00133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 501</name>
      <address>
        <city>Torino</city>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 303</name>
      <address>
        <city>Amsterdam</city>
        <zip>1100</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 302</name>
      <address>
        <city>Nijmegen</city>
        <zip>6500</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 603</name>
      <address>
        <city>Bucharest</city>
        <zip>021105</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 601</name>
      <address>
        <city>Bucharest</city>
        <zip>022328</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 602</name>
      <address>
        <city>Bucharest</city>
        <zip>022328</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 703</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 707</name>
      <address>
        <city>Majadahonda</city>
        <zip>28222</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 705</name>
      <address>
        <city>Malaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 706</name>
      <address>
        <city>Santander</city>
        <zip>39008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 701</name>
      <address>
        <city>Sevilla</city>
        <zip>41014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 802</name>
      <address>
        <city>Camberley</city>
        <zip>GU16 7UJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 808</name>
      <address>
        <city>Hull</city>
        <zip>HU3 2JZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 801</name>
      <address>
        <city>Newcastle Upon Tyne</city>
        <zip>NE7 7DN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 803</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>Germany</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Romania</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>September 24, 2012</study_first_submitted>
  <study_first_submitted_qc>September 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <results_first_submitted>April 26, 2022</results_first_submitted>
  <results_first_submitted_qc>November 2, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">November 3, 2022</results_first_posted>
  <last_update_submitted>November 2, 2022</last_update_submitted>
  <last_update_submitted_qc>November 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PPARs</keyword>
  <keyword>NASH</keyword>
  <keyword>Non-Alcoholic Steatohepatitis</keyword>
  <keyword>Liver Diseases</keyword>
  <keyword>Fibrosis</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>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment for the GFT505-212-7 study began in September 2012. This was a phase IIb, double-blind, randomized, placebo-controlled study conducted in three parallel groups: placebo, GFT505 80mg and GFT505 120mg (after DSMB review of 6 month safety data of the 80mg dose on at least 50% of participants) once daily for 52 weeks.</recruitment_details>
      <pre_assignment_details>Random allocation was done in two phases. In the first study phase, participants were randomly allocated to GFT505 80 mg or placebo (ratio 2:1). In the second study phase (after Data and Safety Monitoring Board review of 6-month safety data of the 80-mg dose on at least 50% of participants), participants were assigned to GFT505 120 mg or placebo (ratio 2:1) in order to balance the 3 treatments in a 1:1:1 ratio basis.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>GFT505 80mg</title>
          <description>Hard gelatin capsules dosed at 40mg, oral administration.&#xD;
3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.</description>
        </group>
        <group group_id="P2">
          <title>GFT505 120mg</title>
          <description>Hard gelatin capsules dosed at 40mg, oral administration.&#xD;
3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.</description>
        </group>
        <group group_id="P3">
          <title>Placebo</title>
          <description>Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions.&#xD;
3 placebo capsules per day, before breakfast with a glass of water.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Treatment Period (Visit 2 to Visit 8)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="93"/>
                <participants group_id="P2" count="90"/>
                <participants group_id="P3" count="92"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Randomized</title>
              <participants_list>
                <participants group_id="P1" count="93"/>
                <participants group_id="P2" count="90"/>
                <participants group_id="P3" count="92"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Randomised and Received Treatment (Full Analysis Set and Safety Set)</title>
              <participants_list>
                <participants group_id="P1" count="93"/>
                <participants group_id="P2" count="89"/>
                <participants group_id="P3" count="92"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Efficacy Evaluable Set</title>
              <participants_list>
                <participants group_id="P1" count="82"/>
                <participants group_id="P2" count="78"/>
                <participants group_id="P3" count="77"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="84"/>
                <participants group_id="P2" count="79"/>
                <participants group_id="P3" count="78"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="11"/>
                <participants group_id="P3" count="14"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="4"/>
              </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="3"/>
                <participants group_id="P3" count="7"/>
              </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="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <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="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-compliance</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Randomized and not treated</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Follow-up Period (to Visit 9)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="84"/>
                <participants group_id="P2" count="79"/>
                <participants group_id="P3" count="78"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="83"/>
                <participants group_id="P2" count="76"/>
                <participants group_id="P3" count="77"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>GFT505 80mg</title>
          <description>Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.</description>
        </group>
        <group group_id="B2">
          <title>GFT505 120mg</title>
          <description>Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.</description>
        </group>
        <group group_id="B3">
          <title>Placebo</title>
          <description>Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions.&#xD;
3 placebo capsules per day, before breakfast with a glass of water.</description>
        </group>
        <group group_id="B4">
          <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="93"/>
            <count group_id="B2" value="89"/>
            <count group_id="B3" value="92"/>
            <count group_id="B4" value="274"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>Data collected at Visit 1</description>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53.26" spread="11.02"/>
                    <measurement group_id="B2" value="52.88" spread="11.63"/>
                    <measurement group_id="B3" value="52.88" spread="11.99"/>
                    <measurement group_id="B4" value="53.01" spread="11.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <description>Data collected at Visit 1</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="37"/>
                    <measurement group_id="B4" value="123"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="55"/>
                    <measurement group_id="B4" value="151"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <description>Data collected at Visit 1</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race</title>
              <category_list>
                <category>
                  <title>Caucasian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="88"/>
                    <measurement group_id="B2" value="71"/>
                    <measurement group_id="B3" value="85"/>
                    <measurement group_id="B4" value="244"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <description>Data collected at Visit 2</description>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31.80" spread="5.20"/>
                    <measurement group_id="B2" value="31.04" spread="4.39"/>
                    <measurement group_id="B3" value="30.91" spread="4.15"/>
                    <measurement group_id="B4" value="31.25" spread="4.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Type 2 diabetes</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Type 2 diabetes (Yes)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="33"/>
                    <measurement group_id="B4" value="107"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 2 diabetes (No)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56"/>
                    <measurement group_id="B2" value="52"/>
                    <measurement group_id="B3" value="59"/>
                    <measurement group_id="B4" value="167"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <description>Data collected at Visit 1</description>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="167.77" spread="9.30"/>
                    <measurement group_id="B2" value="170.21" spread="10.69"/>
                    <measurement group_id="B3" value="169.21" spread="10.23"/>
                    <measurement group_id="B4" value="169.05" spread="10.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <description>Data collected at Visit 2</description>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="89.62" spread="17.76"/>
                    <measurement group_id="B2" value="90.15" spread="15.57"/>
                    <measurement group_id="B3" value="88.72" spread="15.79"/>
                    <measurement group_id="B4" value="89.49" spread="16.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Waist Circumference</title>
          <description>Data collected at Visit 2</description>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="106.41" spread="13.09"/>
                    <measurement group_id="B2" value="106.26" spread="10.28"/>
                    <measurement group_id="B3" value="104.68" spread="10.52"/>
                    <measurement group_id="B4" value="105.78" spread="11.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Responders With Disappearance of Steatohepatitis Without Worsening of Fibrosis (ie, Participants no Longer Meeting the Criteria for Steatohepatitis)</title>
        <description>Percentage of responders from baseline to Week 52 defined by the disappearance of steatohepatitis (ie, participants no longer meeting the criteria for steatohepatitis) without worsening of fibrosis.&#xD;
Worsening of fibrosis was evaluated using Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) fibrosis staging system and defined as:&#xD;
Progression to stage 3 or 4 for participants at stage 0, 1 or 2 on diagnostic liver biopsy&#xD;
Progression to stage 4 for participants at stage 3 on diagnostic liver biopsy</description>
        <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
        <population>Analysis was done of the efficacy evaluable sample, (Efficacy Evaluable Set) formed by participants with liver biopsy available at end-of-treatment and considered as the Intent to Treat population in the protocol. Robustness analysis was also performed in the Full Analysis Set, formed by all randomized participants that received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>GFT505 80mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration.&#xD;
3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.</description>
          </group>
          <group group_id="O2">
            <title>GFT505 120mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions.&#xD;
3 placebo capsules per day, before breakfast with a glass of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Responders With Disappearance of Steatohepatitis Without Worsening of Fibrosis (ie, Participants no Longer Meeting the Criteria for Steatohepatitis)</title>
          <description>Percentage of responders from baseline to Week 52 defined by the disappearance of steatohepatitis (ie, participants no longer meeting the criteria for steatohepatitis) without worsening of fibrosis.&#xD;
Worsening of fibrosis was evaluated using Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) fibrosis staging system and defined as:&#xD;
Progression to stage 3 or 4 for participants at stage 0, 1 or 2 on diagnostic liver biopsy&#xD;
Progression to stage 4 for participants at stage 3 on diagnostic liver biopsy</description>
          <population>Analysis was done of the efficacy evaluable sample, (Efficacy Evaluable Set) formed by participants with liver biopsy available at end-of-treatment and considered as the Intent to Treat population in the protocol. Robustness analysis was also performed in the Full Analysis Set, formed by all randomized participants that received at least one dose of study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="93"/>
                <count group_id="O2" value="89"/>
                <count group_id="O3" value="92"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Efficacy evaluable set</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="82"/>
                    <count group_id="O2" value="78"/>
                    <count group_id="O3" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Responders</title>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="19"/>
                    <measurement group_id="O3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Non-responders</title>
                  <measurement_list>
                    <measurement group_id="O1" value="61"/>
                    <measurement group_id="O2" value="59"/>
                    <measurement group_id="O3" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Full analysis set</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="93"/>
                    <count group_id="O2" value="89"/>
                    <count group_id="O3" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Responders</title>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="19"/>
                    <measurement group_id="O3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Non-responders</title>
                  <measurement_list>
                    <measurement group_id="O1" value="72"/>
                    <measurement group_id="O2" value="70"/>
                    <measurement group_id="O3" value="76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>H_01: OR_80 less than or equal to 1 versus H_11 : OR_80 greater than 1 H_02: OR_120 less than or equal to 1 versus H_12 : OR_120 greater than 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8539</p_value>
            <p_value_desc>To deal with multiplicity of comparisons, a step-down approach was adopted to control the type I error to 0.05. The contrast GFT120 mg versus placebo was examined first. If not significant the GFT 80mg versus placebo contrast was not examined.</p_value_desc>
            <method>Regression, Logistic</method>
            <method_desc>Baseline NAS, Log transformed baseline aspartate aminotransferase and baseline plasminogen activator inhibitor 1 values</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.092</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.427</ci_lower_limit>
            <ci_upper_limit>2.795</ci_upper_limit>
            <estimate_desc>Standard error of the estimate</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>H_01: OR_80 less than or equal to 1 versus H_11 : OR_80 greater than 1 H_02: OR_120 less than or equal to 1 versus H_12 : OR_120 greater than 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8160</p_value>
            <p_value_desc>To deal with multiplicity of comparisons, a step-down approach was adopted to control the type I error to 0.05. The contrast GFT120 mg versus placebo was examined first. If not significant the GFT 80mg versus placebo contrast was not examined.</p_value_desc>
            <method>Regression, Logistic</method>
            <method_desc>Baseline NAS, Log transformed baseline aspartate aminotransferase and baseline plasminogen activator inhibitor 1 values</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.897</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.361</ci_lower_limit>
            <ci_upper_limit>2.232</ci_upper_limit>
            <estimate_desc>Standard error of the estimate</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 52 in Non-alcoholic Fatty Liver Disease Activity Score</title>
        <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg the change from baseline to Week 52, in Non-alcoholic Fatty Liver Disease Activity Score (NAS score).&#xD;
NAS score is a composite score equal to the sum of the steatosis grade (0 to 3), lobular inflammation grade (0 to 3) and hepatocellular ballooning grade (0 to 2). The overall scale of the NAS is 0 to 8, with higher scores indicating more severe disease. The outcome measure, change from baseline in NAFLD Activity Score (NAS), has a possible range from -8 to +8, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.</description>
        <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
        <population>Efficacy evaluable set</population>
        <group_list>
          <group group_id="O1">
            <title>GFT505 80mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration.&#xD;
3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.</description>
          </group>
          <group group_id="O2">
            <title>GFT505 120mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions.&#xD;
3 placebo capsules per day, before breakfast with a glass of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 52 in Non-alcoholic Fatty Liver Disease Activity Score</title>
          <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg the change from baseline to Week 52, in Non-alcoholic Fatty Liver Disease Activity Score (NAS score).&#xD;
NAS score is a composite score equal to the sum of the steatosis grade (0 to 3), lobular inflammation grade (0 to 3) and hepatocellular ballooning grade (0 to 2). The overall scale of the NAS is 0 to 8, with higher scores indicating more severe disease. The outcome measure, change from baseline in NAFLD Activity Score (NAS), has a possible range from -8 to +8, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.</description>
          <population>Efficacy evaluable set</population>
          <units>NAS score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.65" spread="1.33"/>
                    <measurement group_id="O2" value="-0.64" spread="1.68"/>
                    <measurement group_id="O3" value="-0.45" spread="1.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>H0: difference in least squares (LS) mean change from baseline equal to 0 H1: difference in LS mean change from baseline not equal to 0&#xD;
Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.225</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline Non-Alcoholic Fatty Liver Disease Activity Score</method_desc>
            <param_type>difference in least square mean change</param_type>
            <param_value>-0.27</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.75</ci_lower_limit>
            <ci_upper_limit>0.2</ci_upper_limit>
            <estimate_desc>Standard error of the least squares mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>H0: difference in least squares (LS) mean change from baseline equal to 0 H1: difference in LS mean change from baseline not equal to 0&#xD;
Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.254</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline Non-Alcoholic Fatty Liver Disease Activity Score</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-0.28</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.76</ci_lower_limit>
            <ci_upper_limit>0.2</ci_upper_limit>
            <estimate_desc>Standard error of the least squares mean</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Change From Baseline to Week 52 in Non-alcoholic Fatty Liver Disease Activity Score of at Least 2 Points</title>
        <description>To evaluate the number of participants with at least a 2 point decrease from baseline in Non-alcoholic Fatty Liver Disease Activity Score (NAS) after 52 weeks of daily administration of GFT505 80mg or 120mg. The NAS refers to the severity of ongoing liver injury as assessed by a liver biopsy and is used to assess the activity of the disease. It is based on the NASH CRN methodology for scoring the severity of steatosis (score of 0 to 3), inflammation (score of 0 to 3), and hepatocellular ballooning (score of 0 to 2), with a maximum score of 8. A total NAS score of five or greater correlates with the diagnosis of steatohepatitis.&#xD;
In table below for raw &quot;Mild (Nonalcoholic Fatty Liver Disease Activity Score 3)&quot; and the column &quot;GFT505 80mg&quot; the result should be read as : 2 participants (out of 10 participants analysed with a baseline NAS at 3) had at Least 2 points decrease on their NAS after 52 weeks of daily administration of GFT505 80mg. It corresponds to 20% (2 out of 10).</description>
        <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
        <population>Efficacy evaluable set</population>
        <group_list>
          <group group_id="O1">
            <title>GFT505 80mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration.&#xD;
3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.</description>
          </group>
          <group group_id="O2">
            <title>GFT505 120mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions.&#xD;
3 placebo capsules per day, before breakfast with a glass of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Change From Baseline to Week 52 in Non-alcoholic Fatty Liver Disease Activity Score of at Least 2 Points</title>
          <description>To evaluate the number of participants with at least a 2 point decrease from baseline in Non-alcoholic Fatty Liver Disease Activity Score (NAS) after 52 weeks of daily administration of GFT505 80mg or 120mg. The NAS refers to the severity of ongoing liver injury as assessed by a liver biopsy and is used to assess the activity of the disease. It is based on the NASH CRN methodology for scoring the severity of steatosis (score of 0 to 3), inflammation (score of 0 to 3), and hepatocellular ballooning (score of 0 to 2), with a maximum score of 8. A total NAS score of five or greater correlates with the diagnosis of steatohepatitis.&#xD;
In table below for raw &quot;Mild (Nonalcoholic Fatty Liver Disease Activity Score 3)&quot; and the column &quot;GFT505 80mg&quot; the result should be read as : 2 participants (out of 10 participants analysed with a baseline NAS at 3) had at Least 2 points decrease on their NAS after 52 weeks of daily administration of GFT505 80mg. It corresponds to 20% (2 out of 10).</description>
          <population>Efficacy evaluable set</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mild (Non-alcoholic Fatty Liver Disease Activity Score 3)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate (Non-alcoholic Fatty Liver Disease Activity Score 4-5)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                    <count group_id="O2" value="40"/>
                    <count group_id="O3" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe (Non-alcoholic Fatty Liver Disease Activity Score 6-8)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="27"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="82"/>
                    <count group_id="O2" value="78"/>
                    <count group_id="O3" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="26"/>
                    <measurement group_id="O3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8586</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Baseline Non-Alcoholic Fatty Liver Disease Activity Score.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.073</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.493</ci_lower_limit>
            <ci_upper_limit>2.339</ci_upper_limit>
            <estimate_desc>Standard error of the estimate</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2265</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Baseline Non-Alcoholic Fatty Liver Disease Activity Score</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.601</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.747</ci_lower_limit>
            <ci_upper_limit>3.432</ci_upper_limit>
            <estimate_desc>Standard error of the estimate</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Decrease in Steatosis Score of at Least 1 Point Between Baseline and Week 52</title>
        <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, number of participants with a decrease in steatosis score of at least 1 point between baseline and Week 52.&#xD;
Steatosis is assessed by a liver biopsy and evaluated on a scale of 0 to 3 with higher scores indicating more severe steatosis. A score of 0 indicating a lower severity with low parenchymal involvement (&lt;5%), while a score of 3 is indicative of higher involvment/severity (&gt; 66%).&#xD;
In below table and for helping how results are reported, as an example for raw &quot;Mild (Nonalcoholic Fatty Liver Disease Activity Score 3)&quot; and the column &quot;GFT505 80mg&quot; the result should be read as : 1 participants (out of 10 participants analysed with a baseline NAS at 3) had at least 1 point decrease Steatosis Score after 52 weeks of daily administration of GFT505 80mg. It corresponds to 10% (1 out of 10).</description>
        <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
        <population>Efficacy evaluable set</population>
        <group_list>
          <group group_id="O1">
            <title>GFT505 80mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration.&#xD;
3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.</description>
          </group>
          <group group_id="O2">
            <title>GFT505 120mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions.&#xD;
3 placebo capsules per day, before breakfast with a glass of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Decrease in Steatosis Score of at Least 1 Point Between Baseline and Week 52</title>
          <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, number of participants with a decrease in steatosis score of at least 1 point between baseline and Week 52.&#xD;
Steatosis is assessed by a liver biopsy and evaluated on a scale of 0 to 3 with higher scores indicating more severe steatosis. A score of 0 indicating a lower severity with low parenchymal involvement (&lt;5%), while a score of 3 is indicative of higher involvment/severity (&gt; 66%).&#xD;
In below table and for helping how results are reported, as an example for raw &quot;Mild (Nonalcoholic Fatty Liver Disease Activity Score 3)&quot; and the column &quot;GFT505 80mg&quot; the result should be read as : 1 participants (out of 10 participants analysed with a baseline NAS at 3) had at least 1 point decrease Steatosis Score after 52 weeks of daily administration of GFT505 80mg. It corresponds to 10% (1 out of 10).</description>
          <population>Efficacy evaluable set</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mild (Non-Alcoholic Fatty Liver Disease Activity Score 3)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate (Non-Alcoholic Fatty Liver Disease Activity Score 4-5)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                    <count group_id="O2" value="40"/>
                    <count group_id="O3" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe (Non-Alcoholic Fatty Liver Disease Activity Score 6-8)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="27"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="82"/>
                    <count group_id="O2" value="78"/>
                    <count group_id="O3" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="21"/>
                    <measurement group_id="O3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5231</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Baseline value of the analyzed parameter</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.723</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.267</ci_lower_limit>
            <ci_upper_limit>1.958</ci_upper_limit>
            <estimate_desc>Standard error of the estimate</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8459</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Baseline value of the analyzed parameter</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.102</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.415</ci_lower_limit>
            <ci_upper_limit>2.924</ci_upper_limit>
            <estimate_desc>Standard error of the estimate</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Decrease in Lobular Inflammation Score of at Least 1 Point Between Baseline and Week 52</title>
        <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, number of participants with a decrease in lobular inflammation score of at least 1 point between baseline and Week 52.&#xD;
Lobular inflammation is assessed by a liver biopsy and evaluated on a scale of 0 to 3. A score of 0 indicating the absence of inflammation loci, while a score of 3 is indicative of a higher degree of inflammation with more than 4 inflammation loci 200 x field.&#xD;
In below table and for helping how results are reported, as an example for raw &quot;Mild (Nonalcoholic Fatty Liver Disease Activity Score 3)&quot; and the column &quot;GFT505 80mg&quot; the result should be read as : 1 participants (out of 10 participants analysed with a baseline NAS at 3) had at least 1 point decrease of Lobular Inflammation Score after 52 weeks of daily administration of GFT505 80mg. It corresponds to 10% (1 out of 10).</description>
        <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
        <population>Efficacy evaluable set</population>
        <group_list>
          <group group_id="O1">
            <title>GFT505 80mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration.&#xD;
3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.</description>
          </group>
          <group group_id="O2">
            <title>GFT505 120mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions.&#xD;
3 placebo capsules per day, before breakfast with a glass of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Decrease in Lobular Inflammation Score of at Least 1 Point Between Baseline and Week 52</title>
          <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, number of participants with a decrease in lobular inflammation score of at least 1 point between baseline and Week 52.&#xD;
Lobular inflammation is assessed by a liver biopsy and evaluated on a scale of 0 to 3. A score of 0 indicating the absence of inflammation loci, while a score of 3 is indicative of a higher degree of inflammation with more than 4 inflammation loci 200 x field.&#xD;
In below table and for helping how results are reported, as an example for raw &quot;Mild (Nonalcoholic Fatty Liver Disease Activity Score 3)&quot; and the column &quot;GFT505 80mg&quot; the result should be read as : 1 participants (out of 10 participants analysed with a baseline NAS at 3) had at least 1 point decrease of Lobular Inflammation Score after 52 weeks of daily administration of GFT505 80mg. It corresponds to 10% (1 out of 10).</description>
          <population>Efficacy evaluable set</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mild (Non-Alcoholic Fatty Liver Disease Activity Score 3)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate (Non-Alcoholic Fatty Liver Disease Activity Score 4-5)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                    <count group_id="O2" value="40"/>
                    <count group_id="O3" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe (Non-Alcoholic Fatty Liver Disease Activity Score 6-8)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="27"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="16"/>
                    <measurement group_id="O3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="82"/>
                    <count group_id="O2" value="78"/>
                    <count group_id="O3" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="29"/>
                    <measurement group_id="O3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5229</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Baseline value of the analyzed parameter</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.638</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.161</ci_lower_limit>
            <ci_upper_limit>2.529</ci_upper_limit>
            <estimate_desc>Standard error of the estimate</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5646</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Baseline value of the analyzed parameter</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.433</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>.421</ci_lower_limit>
            <ci_upper_limit>4.875</ci_upper_limit>
            <estimate_desc>Standard error of the estimate</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Title: Number of Participants With Decrease in Ballooning Score of at Least 1 Point Between Baseline and Week 52</title>
        <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, number of participants with a decrease in ballooning score of at least 1 point between baseline and Week 52.&#xD;
Ballooning is assessed by a liver biopsy and evaluated on a scale of 0 to 2 with higher scores indicating more severe ballooning (0: No ballooned cells, 1: Few [rare but definite] ballooned hepatocytes; 2: Many ballooned cells/prominent ballooning).&#xD;
In below table and for helping how results are reported, as an example for raw &quot;Mild (Nonalcoholic Fatty Liver Disease Activity Score 3)&quot; and the column &quot;GFT505 80mg&quot; the result should be read as : 4 participants (out of 10 participants analysed with a baseline NAS at 3) had at least 1 point decrease of Ballooning Score after 52 weeks of daily administration of GFT505 80mg. It corresponds to 10% (1 out of 10).</description>
        <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
        <population>Efficacy evaluable set</population>
        <group_list>
          <group group_id="O1">
            <title>GFT505 80mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration.&#xD;
3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.</description>
          </group>
          <group group_id="O2">
            <title>GFT505 120mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions.&#xD;
3 placebo capsules per day, before breakfast with a glass of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Title: Number of Participants With Decrease in Ballooning Score of at Least 1 Point Between Baseline and Week 52</title>
          <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, number of participants with a decrease in ballooning score of at least 1 point between baseline and Week 52.&#xD;
Ballooning is assessed by a liver biopsy and evaluated on a scale of 0 to 2 with higher scores indicating more severe ballooning (0: No ballooned cells, 1: Few [rare but definite] ballooned hepatocytes; 2: Many ballooned cells/prominent ballooning).&#xD;
In below table and for helping how results are reported, as an example for raw &quot;Mild (Nonalcoholic Fatty Liver Disease Activity Score 3)&quot; and the column &quot;GFT505 80mg&quot; the result should be read as : 4 participants (out of 10 participants analysed with a baseline NAS at 3) had at least 1 point decrease of Ballooning Score after 52 weeks of daily administration of GFT505 80mg. It corresponds to 10% (1 out of 10).</description>
          <population>Efficacy evaluable set</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mild (Non-Alcoholic Fatty Liver Disease Activity Score 3)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate (Non-Alcoholic Fatty Liver Disease Activity Score 4-5)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                    <count group_id="O2" value="40"/>
                    <count group_id="O3" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe (Non-Alcoholic Fatty Liver Disease Activity Score 6-8)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="27"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="82"/>
                    <count group_id="O2" value="78"/>
                    <count group_id="O3" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="30"/>
                    <measurement group_id="O3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1983</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Baseline value of the analyzed parameter</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.382</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.088</ci_lower_limit>
            <ci_upper_limit>1.656</ci_upper_limit>
            <estimate_desc>Standard error of the estimate</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>1.0000</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Baseline value of the analyzed parameter</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.000</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.288</ci_lower_limit>
            <ci_upper_limit>3.466</ci_upper_limit>
            <estimate_desc>Standard error of the estimate</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes From Baseline to Week 52 in the Stages of Fibrosis</title>
        <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in stages of fibrosis (based on Non-Alcoholic Steatohepatitis Clinical Research Network [NASH CRN] scoring).&#xD;
Fibrosis is assessed on a scale of 0 to 4 with higher scores indicating more severe fibrosis.</description>
        <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
        <population>Efficacy evaluable set</population>
        <group_list>
          <group group_id="O1">
            <title>GFT505 80mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration.&#xD;
3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.</description>
          </group>
          <group group_id="O2">
            <title>GFT505 120mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions.&#xD;
3 placebo capsules per day, before breakfast with a glass of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes From Baseline to Week 52 in the Stages of Fibrosis</title>
          <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in stages of fibrosis (based on Non-Alcoholic Steatohepatitis Clinical Research Network [NASH CRN] scoring).&#xD;
Fibrosis is assessed on a scale of 0 to 4 with higher scores indicating more severe fibrosis.</description>
          <population>Efficacy evaluable set</population>
          <units>Change in fibrosis score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.23" spread="0.84"/>
                    <measurement group_id="O2" value="-0.06" spread="0.96"/>
                    <measurement group_id="O3" value="-0.23" spread="0.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3543</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Baseline value of the analyzed parameter</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.653</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.265</ci_lower_limit>
            <ci_upper_limit>1.609</ci_upper_limit>
            <estimate_desc>Standard error of the estimate</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5780</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Baseline value of the analyzed parameter</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.270</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.547</ci_lower_limit>
            <ci_upper_limit>2.953</ci_upper_limit>
            <estimate_desc>Standard error of the estimate</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes From Baseline to Visit 8 (Week 52) in Liver Enzymes</title>
        <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to week 52, in liver enzymes.</description>
        <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
        <population>Efficacy evaluable set</population>
        <group_list>
          <group group_id="O1">
            <title>GFT505 80mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration.&#xD;
3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.</description>
          </group>
          <group group_id="O2">
            <title>GFT505 120mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions.&#xD;
3 placebo capsules per day, before breakfast with a glass of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes From Baseline to Visit 8 (Week 52) in Liver Enzymes</title>
          <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to week 52, in liver enzymes.</description>
          <population>Efficacy evaluable set</population>
          <units>U/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Gamma-glutamyl transferase</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-24.32" spread="36.39"/>
                    <measurement group_id="O2" value="-20.59" spread="40.45"/>
                    <measurement group_id="O3" value="6.22" spread="50.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Aspartate transaminase</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.88" spread="27.76"/>
                    <measurement group_id="O2" value="-1.37" spread="24.74"/>
                    <measurement group_id="O3" value="-1.32" spread="16.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alanine aminotransferase</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.02" spread="36.21"/>
                    <measurement group_id="O2" value="-12.54" spread="44.72"/>
                    <measurement group_id="O3" value="-3.26" spread="24.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alkaline phosphatases</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-18.82" spread="13.23"/>
                    <measurement group_id="O2" value="-20.44" spread="16.47"/>
                    <measurement group_id="O3" value="3.44" spread="13.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Change in aspartate transaminase (U/L)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.711</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>1.24</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.33</ci_lower_limit>
            <ci_upper_limit>7.81</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Change in aspartate transaminase (U/L)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.78</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-0.94</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.58</ci_lower_limit>
            <ci_upper_limit>5.7</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Change in alanine aminotransferase (U/L)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.221</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-6.13</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-15.97</ci_lower_limit>
            <ci_upper_limit>3.71</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Change in alanine aminotransferase (U/L)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.062</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-9.45</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-19.4</ci_lower_limit>
            <ci_upper_limit>0.49</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Change in Alkaline phosphatases (U/L)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-23.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-27.16</ci_lower_limit>
            <ci_upper_limit>-18.88</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Change in Alkaline phosphatases (U/L)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-23.85</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-28.04</ci_lower_limit>
            <ci_upper_limit>2.12</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Change in Gamma-glutamyl transferase (U/L)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-31.41</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-43.78</ci_lower_limit>
            <ci_upper_limit>-19.05</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Change in Gamma-glutamyl transferase (U/L)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-29.31</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-41.84</ci_lower_limit>
            <ci_upper_limit>-16.77</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes From Baseline to Visit 8 (Week 52) in Aspartate Transaminase/Alanine Aminotransferase Ratio</title>
        <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to week 52, in aspartate transaminase/alanine aminotransferase ratio</description>
        <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
        <population>Efficacy evaluable set</population>
        <group_list>
          <group group_id="O1">
            <title>GFT505 80mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration.&#xD;
3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.</description>
          </group>
          <group group_id="O2">
            <title>GFT505 120mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions.&#xD;
3 placebo capsules per day, before breakfast with a glass of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes From Baseline to Visit 8 (Week 52) in Aspartate Transaminase/Alanine Aminotransferase Ratio</title>
          <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to week 52, in aspartate transaminase/alanine aminotransferase ratio</description>
          <population>Efficacy evaluable set</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.15" spread="0.21"/>
                    <measurement group_id="O2" value="0.20" spread="0.25"/>
                    <measurement group_id="O3" value="0.01" spread="0.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>0.14</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.06</ci_lower_limit>
            <ci_upper_limit>0.21</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>0.19</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.11</ci_lower_limit>
            <ci_upper_limit>0.26</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: CK 18-M65</title>
        <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in CK 18-M65 (non-invasive markers of fibrosis and steatosis).</description>
        <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
        <population>Efficacy evaluable set</population>
        <group_list>
          <group group_id="O1">
            <title>GFT505 80mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration.&#xD;
3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.</description>
          </group>
          <group group_id="O2">
            <title>GFT505 120mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions.&#xD;
3 placebo capsules per day, before breakfast with a glass of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: CK 18-M65</title>
          <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in CK 18-M65 (non-invasive markers of fibrosis and steatosis).</description>
          <population>Efficacy evaluable set</population>
          <units>U/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="104.4" spread="804.96"/>
                    <measurement group_id="O2" value="-185.01" spread="658.14"/>
                    <measurement group_id="O3" value="-45.53" spread="437.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <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>0.095</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>141.78</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-24.99</ci_lower_limit>
            <ci_upper_limit>308.55</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.412</p_value>
            <p_value_desc>Baseline parameter value and presence of diabetes as random factors</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-70.57</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-239.85</ci_lower_limit>
            <ci_upper_limit>98.71</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: CK18 M30</title>
        <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in CK18 M30 (non-invasive markers of fibrosis and steatosis).&#xD;
Participants with missing data for CK18 M30 at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the &quot;Efficacy Evaluable Set&quot; of the Participant Flow.</description>
        <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
        <population>Efficacy evaluable set</population>
        <group_list>
          <group group_id="O1">
            <title>GFT505 80mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration.&#xD;
3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.</description>
          </group>
          <group group_id="O2">
            <title>GFT505 120mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions.&#xD;
3 placebo capsules per day, before breakfast with a glass of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: CK18 M30</title>
          <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in CK18 M30 (non-invasive markers of fibrosis and steatosis).&#xD;
Participants with missing data for CK18 M30 at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the &quot;Efficacy Evaluable Set&quot; of the Participant Flow.</description>
          <population>Efficacy evaluable set</population>
          <units>pmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-28.08" spread="574.50"/>
                    <measurement group_id="O2" value="-66.40" spread="432.02"/>
                    <measurement group_id="O3" value="-51.39" spread="349.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <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>0.592</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>32.39</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-86.63</ci_lower_limit>
            <ci_upper_limit>151.42</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.61</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>31.35</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-89.42</ci_lower_limit>
            <ci_upper_limit>152.12</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Adiponectin</title>
        <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in adiponectin (non-invasive markers of fibrosis and steatosis).</description>
        <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
        <population>Efficacy evaluable set</population>
        <group_list>
          <group group_id="O1">
            <title>GFT505 80mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration.&#xD;
3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.</description>
          </group>
          <group group_id="O2">
            <title>GFT505 120mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions.&#xD;
3 placebo capsules per day, before breakfast with a glass of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Adiponectin</title>
          <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in adiponectin (non-invasive markers of fibrosis and steatosis).</description>
          <population>Efficacy evaluable set</population>
          <units>μg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.98" spread="20.25"/>
                    <measurement group_id="O2" value="1.90" spread="8.34"/>
                    <measurement group_id="O3" value="2.54" spread="9.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <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>0.459</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>1.67</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.77</ci_lower_limit>
            <ci_upper_limit>6.11</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.764</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-0.67</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.06</ci_lower_limit>
            <ci_upper_limit>3.72</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Ferritin</title>
        <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in ferritin (non-invasive markers of fibrosis and steatosis).&#xD;
Participants with missing data for Ferritin at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the &quot;Efficacy Evaluable Set&quot; of the Participant Flow.</description>
        <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
        <population>Efficacy evaluable set</population>
        <group_list>
          <group group_id="O1">
            <title>GFT505 80mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration.&#xD;
3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.</description>
          </group>
          <group group_id="O2">
            <title>GFT505 120mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions.&#xD;
3 placebo capsules per day, before breakfast with a glass of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Ferritin</title>
          <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in ferritin (non-invasive markers of fibrosis and steatosis).&#xD;
Participants with missing data for Ferritin at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the &quot;Efficacy Evaluable Set&quot; of the Participant Flow.</description>
          <population>Efficacy evaluable set</population>
          <units>μg/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
                <count group_id="O2" value="77"/>
                <count group_id="O3" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-23.52" spread="145.61"/>
                    <measurement group_id="O2" value="-19.68" spread="81.91"/>
                    <measurement group_id="O3" value="-19.26" spread="122.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <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>0.466</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-12.92</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-47.79</ci_lower_limit>
            <ci_upper_limit>21.95</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.745</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-5.82</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-41.07</ci_lower_limit>
            <ci_upper_limit>29.42</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: FG19 and FG21</title>
        <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in FG19 and FG21 (non-invasive markers of fibrosis and steatosis).</description>
        <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
        <population>Efficacy evaluable set</population>
        <group_list>
          <group group_id="O1">
            <title>GFT505 80mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration.&#xD;
3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.</description>
          </group>
          <group group_id="O2">
            <title>GFT505 120mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions.&#xD;
3 placebo capsules per day, before breakfast with a glass of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: FG19 and FG21</title>
          <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in FG19 and FG21 (non-invasive markers of fibrosis and steatosis).</description>
          <population>Efficacy evaluable set</population>
          <units>pg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>FG19</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-27.25" spread="94.19"/>
                    <measurement group_id="O2" value="-26.03" spread="91.59"/>
                    <measurement group_id="O3" value="11.64" spread="87.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FG21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="258.74" spread="1138.36"/>
                    <measurement group_id="O2" value="319.68" spread="433.63"/>
                    <measurement group_id="O3" value="73.05" spread="360.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>FG19</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.018</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-26.57</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-48.59</ci_lower_limit>
            <ci_upper_limit>-4.54</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>FG19</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-40.39</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-62.61</ci_lower_limit>
            <ci_upper_limit>-18.17</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>FG21</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.101</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>190.07</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-37.38</ci_lower_limit>
            <ci_upper_limit>417.52</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>FG21</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.052</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>228.33</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.16</ci_lower_limit>
            <ci_upper_limit>458.82</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Alpha2 Macroglobulin</title>
        <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in alpha2 macroglobulin (a non-invasive marker of fibrosis and steatosis).&#xD;
Participants with missing data for Alpha2 Macroglobulin at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the &quot;Efficacy Evaluable Set&quot; of the Participant Flow.</description>
        <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
        <population>Efficacy evaluable set</population>
        <group_list>
          <group group_id="O1">
            <title>GFT505 80mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration.&#xD;
3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.</description>
          </group>
          <group group_id="O2">
            <title>GFT505 120mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions.&#xD;
3 placebo capsules per day, before breakfast with a glass of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Alpha2 Macroglobulin</title>
          <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in alpha2 macroglobulin (a non-invasive marker of fibrosis and steatosis).&#xD;
Participants with missing data for Alpha2 Macroglobulin at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the &quot;Efficacy Evaluable Set&quot; of the Participant Flow.</description>
          <population>Efficacy evaluable set</population>
          <units>g/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
                <count group_id="O2" value="77"/>
                <count group_id="O3" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.14" spread="0.29"/>
                    <measurement group_id="O2" value="-0.26" spread="0.36"/>
                    <measurement group_id="O3" value="0.01" spread="0.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <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>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-0.14</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.29</ci_lower_limit>
            <ci_upper_limit>-0.01</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-0.24</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.34</ci_lower_limit>
            <ci_upper_limit>-0.15</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Hyaluronic Acid, N-terminal Pro-peptide of Collagen Type III (PIIINP), and Tissue Inhibitor of Matrix Metalloprotease-1 (TIMP-1)</title>
        <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in hyaluronic acid, N-terminal pro-peptide of collagen type III (PIIINP), and tissue inhibitor of matrix metalloprotease-1 (TIMP-1) (non-invasive markers of fibrosis and steatosis).</description>
        <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
        <population>Efficacy evaluable set</population>
        <group_list>
          <group group_id="O1">
            <title>GFT505 80mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration.&#xD;
3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.</description>
          </group>
          <group group_id="O2">
            <title>GFT505 120mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions.&#xD;
3 placebo capsules per day, before breakfast with a glass of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Hyaluronic Acid, N-terminal Pro-peptide of Collagen Type III (PIIINP), and Tissue Inhibitor of Matrix Metalloprotease-1 (TIMP-1)</title>
          <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in hyaluronic acid, N-terminal pro-peptide of collagen type III (PIIINP), and tissue inhibitor of matrix metalloprotease-1 (TIMP-1) (non-invasive markers of fibrosis and steatosis).</description>
          <population>Efficacy evaluable set</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hyaluronic acid</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="82"/>
                    <count group_id="O2" value="78"/>
                    <count group_id="O3" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.12" spread="230.97"/>
                    <measurement group_id="O2" value="12.14" spread="48.04"/>
                    <measurement group_id="O3" value="12.49" spread="48.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PIIINP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="78"/>
                    <count group_id="O3" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.50" spread="3.43"/>
                    <measurement group_id="O2" value="-0.57" spread="3.75"/>
                    <measurement group_id="O3" value="0.29" spread="4.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TIMP-1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="78"/>
                    <count group_id="O3" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.21" spread="35.38"/>
                    <measurement group_id="O2" value="-6.32" spread="39.75"/>
                    <measurement group_id="O3" value="9.08" spread="49.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Hyaluronic acid</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.203</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-16.54</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-42.07</ci_lower_limit>
            <ci_upper_limit>8.98</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.603</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-6.79</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-32.49</ci_lower_limit>
            <ci_upper_limit>18.9</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>PIIINP</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.235</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-0.73</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.95</ci_lower_limit>
            <ci_upper_limit>0.48</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>PIIINP</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.193</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-0.81</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.04</ci_lower_limit>
            <ci_upper_limit>0.41</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>TIMP-1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.348</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>6.21</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.81</ci_lower_limit>
            <ci_upper_limit>19.22</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>TIMP-1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.029</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-14.66</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-27.81</ci_lower_limit>
            <ci_upper_limit>1.51</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Fibrotest</title>
        <description>Fibrotest combines α2-macroglobulin (a2m), apolipoprotein A1 (aA1), total bilirubin (BIL), haptoglobin (h), GGT, and ALT with adjustment for age and gender. Fibrotest is calculated as: z = 4.467 x log(a2m) - 1.357 x log(h) + 1.017 x log(GGT) + 0.0281 x Age + 1.737 x log(BIL) - 1.184 x (aA1) + 0.301 x Gender - 5.54 where Gender = 1 for male and Gender = 0 for female. The score is then: 1/(1+e^-z). Calculated score range from 0 (no fibrosis) to 1 (severe fibrosis or cirrhosis) In below table for &quot;Fibrotest&quot; and for column &quot;GFT505 80mg&quot; the result should be read as: the mean of change from baseline to week 52 of Fibrotest calculated in 81 participants is -0.06 with a standard deviation of 0.08.</description>
        <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
        <population>Efficacy evaluable set</population>
        <group_list>
          <group group_id="O1">
            <title>GFT505 80mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration.&#xD;
3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.</description>
          </group>
          <group group_id="O2">
            <title>GFT505 120mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions.&#xD;
3 placebo capsules per day, before breakfast with a glass of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Fibrotest</title>
          <description>Fibrotest combines α2-macroglobulin (a2m), apolipoprotein A1 (aA1), total bilirubin (BIL), haptoglobin (h), GGT, and ALT with adjustment for age and gender. Fibrotest is calculated as: z = 4.467 x log(a2m) - 1.357 x log(h) + 1.017 x log(GGT) + 0.0281 x Age + 1.737 x log(BIL) - 1.184 x (aA1) + 0.301 x Gender - 5.54 where Gender = 1 for male and Gender = 0 for female. The score is then: 1/(1+e^-z). Calculated score range from 0 (no fibrosis) to 1 (severe fibrosis or cirrhosis) In below table for &quot;Fibrotest&quot; and for column &quot;GFT505 80mg&quot; the result should be read as: the mean of change from baseline to week 52 of Fibrotest calculated in 81 participants is -0.06 with a standard deviation of 0.08.</description>
          <population>Efficacy evaluable set</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.06" spread="0.08"/>
                    <measurement group_id="O2" value="-0.07" spread="0.09"/>
                    <measurement group_id="O3" value="-0.01" spread="0.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-0.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.07</ci_lower_limit>
            <ci_upper_limit>-0.02</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-0.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.08</ci_lower_limit>
            <ci_upper_limit>-0.02</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Steatotest</title>
        <description>SteatoTest combines α2-macroglobulin, haptoglobin, apolipoprotein A1, total bilirubin, GGT, fasting glucose, triglycerides, cholesterol, and ALT, adjusted for patient's age, sex, weight, and height. Patented formula. Calculated score range from 0 (no steatosis) to 1 (severe steatosis) In below table for &quot;Steatotest&quot; and for column &quot;GFT505 80mg&quot; the result should be read as: the mean of change from baseline to week 52 of Steatotest calculated in 81 participants is -0.09 with a standard deviation of 0.11.</description>
        <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
        <population>Efficacy evaluable set</population>
        <group_list>
          <group group_id="O1">
            <title>GFT505 80mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration.&#xD;
3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.</description>
          </group>
          <group group_id="O2">
            <title>GFT505 120mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions.&#xD;
3 placebo capsules per day, before breakfast with a glass of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Steatotest</title>
          <description>SteatoTest combines α2-macroglobulin, haptoglobin, apolipoprotein A1, total bilirubin, GGT, fasting glucose, triglycerides, cholesterol, and ALT, adjusted for patient's age, sex, weight, and height. Patented formula. Calculated score range from 0 (no steatosis) to 1 (severe steatosis) In below table for &quot;Steatotest&quot; and for column &quot;GFT505 80mg&quot; the result should be read as: the mean of change from baseline to week 52 of Steatotest calculated in 81 participants is -0.09 with a standard deviation of 0.11.</description>
          <population>Efficacy evaluable set</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
                <count group_id="O2" value="77"/>
                <count group_id="O3" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.09" spread="0.11"/>
                    <measurement group_id="O2" value="-0.08" spread="0.15"/>
                    <measurement group_id="O3" value="0.03" spread="0.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-0.11</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.15</ci_lower_limit>
            <ci_upper_limit>-0.07</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-0.11</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.15</ci_lower_limit>
            <ci_upper_limit>-0.07</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Angulo Index or Non-Alcoholic Fatty Liver Disease Fibrosis Score</title>
        <description>Angulo Index or Non-Alcoholic Fatty Liver Disease Fibrosis Score is based on age, hyperglycemia, BMI, platelet count, albumin level, and AST/ALT ratio. Score is calculated using the following formula: -1.675 + 0.037 × age (years) + 0.094 × BMI (kg/m^2) + 1.13 × IFG/diabetes (yes = 1, no = 0) + 0.99 × AST/ALT ratio - 0.013 × platelet (×10^9/l) - 0.66 × albumin (g/dl). A score of &lt;-1.455 indicates no advanced fibrosis and a score of &gt;0.676 indicates liver fibrosis.&#xD;
In below table for &quot;Angulo index&quot; and for column &quot;GFT505 80mg&quot; the result should be read as: the mean of change from baseline to week 52 of Angulo index calculated in 82 participants is 0.06 with a standard deviation of 0.53.</description>
        <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
        <population>Efficacy evaluable set</population>
        <group_list>
          <group group_id="O1">
            <title>GFT505 80mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration.&#xD;
3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.</description>
          </group>
          <group group_id="O2">
            <title>GFT505 120mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions.&#xD;
3 placebo capsules per day, before breakfast with a glass of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Angulo Index or Non-Alcoholic Fatty Liver Disease Fibrosis Score</title>
          <description>Angulo Index or Non-Alcoholic Fatty Liver Disease Fibrosis Score is based on age, hyperglycemia, BMI, platelet count, albumin level, and AST/ALT ratio. Score is calculated using the following formula: -1.675 + 0.037 × age (years) + 0.094 × BMI (kg/m^2) + 1.13 × IFG/diabetes (yes = 1, no = 0) + 0.99 × AST/ALT ratio - 0.013 × platelet (×10^9/l) - 0.66 × albumin (g/dl). A score of &lt;-1.455 indicates no advanced fibrosis and a score of &gt;0.676 indicates liver fibrosis.&#xD;
In below table for &quot;Angulo index&quot; and for column &quot;GFT505 80mg&quot; the result should be read as: the mean of change from baseline to week 52 of Angulo index calculated in 82 participants is 0.06 with a standard deviation of 0.53.</description>
          <population>Efficacy evaluable set</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
                <count group_id="O2" value="75"/>
                <count group_id="O3" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.06" spread="0.53"/>
                    <measurement group_id="O2" value="-0.26" spread="0.57"/>
                    <measurement group_id="O3" value="-0.01" spread="0.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <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>0.471</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>0.06</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.11</ci_lower_limit>
            <ci_upper_limit>0.23</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.005</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-0.25</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.42</ci_lower_limit>
            <ci_upper_limit>-0.08</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Enhanced Liver Fibrosis (ELF)</title>
        <description>Enhanced Liver Fibrosis (ELF) combines measurements of tissue inhibitor of metalloprotein-ases-1 (TIMP-1), amino-terminal propeptide of type III procollagen (PIIINP), and hyaluronic acid (HA) . The ELF score is calculated as : 2.278 + 0.851 ln (HA) + 0.751 ln (PIIINP) + 0.394 ln (TIMP-1). ELF score range from An ELF score of less than 7.7 indicates no fibrosis. An ELF score greater than or equal to 9.8 indicates severe fibrosis. An ELF score of 11.3 or greater indicates cirrhosis. A decrease in ELF score represents a positive outcome In below table for &quot;Enhanced Liver Fibrosis&quot; and for column &quot;GFT505 80mg&quot; the result should be read as : the mean of change from baseline to week 52 of Enhanced Liver Fibrosis calculated in 81 analysed participants is -0.01 with a standard deviation of 0.54.</description>
        <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
        <population>Efficacy evaluable set</population>
        <group_list>
          <group group_id="O1">
            <title>GFT505 80mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration.&#xD;
3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.</description>
          </group>
          <group group_id="O2">
            <title>GFT505 120mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions.&#xD;
3 placebo capsules per day, before breakfast with a glass of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Enhanced Liver Fibrosis (ELF)</title>
          <description>Enhanced Liver Fibrosis (ELF) combines measurements of tissue inhibitor of metalloprotein-ases-1 (TIMP-1), amino-terminal propeptide of type III procollagen (PIIINP), and hyaluronic acid (HA) . The ELF score is calculated as : 2.278 + 0.851 ln (HA) + 0.751 ln (PIIINP) + 0.394 ln (TIMP-1). ELF score range from An ELF score of less than 7.7 indicates no fibrosis. An ELF score greater than or equal to 9.8 indicates severe fibrosis. An ELF score of 11.3 or greater indicates cirrhosis. A decrease in ELF score represents a positive outcome In below table for &quot;Enhanced Liver Fibrosis&quot; and for column &quot;GFT505 80mg&quot; the result should be read as : the mean of change from baseline to week 52 of Enhanced Liver Fibrosis calculated in 81 analysed participants is -0.01 with a standard deviation of 0.54.</description>
          <population>Efficacy evaluable set</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.01" spread="0.54"/>
                    <measurement group_id="O2" value="-0.01" spread="0.64"/>
                    <measurement group_id="O3" value="0.08" spread="0.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <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>0.457</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-0.07</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.27</ci_lower_limit>
            <ci_upper_limit>0.12</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.428</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean</param_type>
            <param_value>-0.08</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.28</ci_lower_limit>
            <ci_upper_limit>0.12</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Fatty Liver Index (FLI)</title>
        <description>The Fatty Liver Index (FLI) combines triglycerides, BMI, GGT and Waist circumference. FLI is calculated as : (e0.953×loge[triglycerides]+0.139× Body Mass Index[BMI]+0.718×loge Gamma- Glutamyl Transferase [GGT]+0.053×waistcircumference-15.745)/ (1 +e0.953×loge[triglycerides]+0.139×BMI+0.718×loge [GGT]+0.053×waistcircumference-15.745) × 100. Calculated index range from 0 to 100. FLI score below 30 indicate absence of Fatty Liver and FLI Score of 60 and above indicates presence of Fatty Liver.&#xD;
In below table for &quot;Fatty Liver Index&quot; and for column &quot;GFT505 80mg&quot; the result should be read as : the mean of change from baseline to week 52 of Fatty Liver Index calculated in 82 analysed participants is -7.94 with a standard deviation of 11.74.</description>
        <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
        <population>Efficacy evaluable set</population>
        <group_list>
          <group group_id="O1">
            <title>GFT505 80mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration.&#xD;
3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.</description>
          </group>
          <group group_id="O2">
            <title>GFT505 120mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions.&#xD;
3 placebo capsules per day, before breakfast with a glass of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Fatty Liver Index (FLI)</title>
          <description>The Fatty Liver Index (FLI) combines triglycerides, BMI, GGT and Waist circumference. FLI is calculated as : (e0.953×loge[triglycerides]+0.139× Body Mass Index[BMI]+0.718×loge Gamma- Glutamyl Transferase [GGT]+0.053×waistcircumference-15.745)/ (1 +e0.953×loge[triglycerides]+0.139×BMI+0.718×loge [GGT]+0.053×waistcircumference-15.745) × 100. Calculated index range from 0 to 100. FLI score below 30 indicate absence of Fatty Liver and FLI Score of 60 and above indicates presence of Fatty Liver.&#xD;
In below table for &quot;Fatty Liver Index&quot; and for column &quot;GFT505 80mg&quot; the result should be read as : the mean of change from baseline to week 52 of Fatty Liver Index calculated in 82 analysed participants is -7.94 with a standard deviation of 11.74.</description>
          <population>Efficacy evaluable set</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
                <count group_id="O2" value="77"/>
                <count group_id="O3" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.94" spread="11.74"/>
                    <measurement group_id="O2" value="-7.81" spread="14.29"/>
                    <measurement group_id="O3" value="1.34" spread="11.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-9.22</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.19</ci_lower_limit>
            <ci_upper_limit>-5.24</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-9.08</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.12</ci_lower_limit>
            <ci_upper_limit>-5.04</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Fibrometer</title>
        <description>Fibrometer combines Platelets, AST, ALT, ferritin, glucose (fasting plasma), Weight and gender. Patented formula. Score ranges from 0 (no fibrosis) to 1 (severe fibrosis or cirrhosis) In below table for &quot;Fibrometer&quot; and for column &quot;GFT505 80mg&quot; the result should be read as : the mean of change from baseline to week 52 of Fibrometer calculated in 81 analysed participants is 0.04 with a standard deviation of 0.23.</description>
        <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
        <population>Efficacy evaluable set</population>
        <group_list>
          <group group_id="O1">
            <title>GFT505 80mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration.&#xD;
3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.</description>
          </group>
          <group group_id="O2">
            <title>GFT505 120mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions.&#xD;
3 placebo capsules per day, before breakfast with a glass of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Fibrometer</title>
          <description>Fibrometer combines Platelets, AST, ALT, ferritin, glucose (fasting plasma), Weight and gender. Patented formula. Score ranges from 0 (no fibrosis) to 1 (severe fibrosis or cirrhosis) In below table for &quot;Fibrometer&quot; and for column &quot;GFT505 80mg&quot; the result should be read as : the mean of change from baseline to week 52 of Fibrometer calculated in 81 analysed participants is 0.04 with a standard deviation of 0.23.</description>
          <population>Efficacy evaluable set</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.04" spread="0.23"/>
                    <measurement group_id="O2" value="0" spread="0.20"/>
                    <measurement group_id="O3" value="0.02" spread="0.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <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>0.531</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>0.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.05</ci_lower_limit>
            <ci_upper_limit>0.09</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.638</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-0.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.08</ci_lower_limit>
            <ci_upper_limit>0.05</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Total Bilirubin and Conjugated Bilirubin</title>
        <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in total bilirubin and conjugated bilirubin (non-invasive markers of fibrosis and steatosis).</description>
        <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
        <population>Efficacy evaluable set</population>
        <group_list>
          <group group_id="O1">
            <title>GFT505 80mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration.&#xD;
3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.</description>
          </group>
          <group group_id="O2">
            <title>GFT505 120mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions.&#xD;
3 placebo capsules per day, before breakfast with a glass of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Total Bilirubin and Conjugated Bilirubin</title>
          <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in total bilirubin and conjugated bilirubin (non-invasive markers of fibrosis and steatosis).</description>
          <population>Efficacy evaluable set</population>
          <units>umol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total bilirubin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.53" spread="3.66"/>
                    <measurement group_id="O2" value="-1.38" spread="4.85"/>
                    <measurement group_id="O3" value="-1.46" spread="3.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Conjugated bilirubin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.35" spread="1.26"/>
                    <measurement group_id="O2" value="-0.15" spread="1.24"/>
                    <measurement group_id="O3" value="-0.26" spread="1.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Total bilirubin</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.831</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-0.14</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.39</ci_lower_limit>
            <ci_upper_limit>1.12</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Total bilirubin</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.754</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>0.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.07</ci_lower_limit>
            <ci_upper_limit>1.47</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Conjugated Bilirubin</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.848</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-0.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.36</ci_lower_limit>
            <ci_upper_limit>0.3</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Conjugated Bilirubin</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.511</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>0.11</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.22</ci_lower_limit>
            <ci_upper_limit>0.45</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Prothrombin Ratio</title>
        <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in prothrombin ratio (non-invasive marker of fibrosis and steatosis).&#xD;
The Prothrombin ratio is the ratio of a participants measured prothrombin time (in seconds) to the normal laboratory reference prothrombin time.&#xD;
Participants with missing data for Prothrombin ratio at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the &quot;Efficacy Evaluable Set&quot; of the Participant Flow.</description>
        <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
        <population>Efficacy evaluable set</population>
        <group_list>
          <group group_id="O1">
            <title>GFT505 80mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration.&#xD;
3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.</description>
          </group>
          <group group_id="O2">
            <title>GFT505 120mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions.&#xD;
3 placebo capsules per day, before breakfast with a glass of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Prothrombin Ratio</title>
          <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in prothrombin ratio (non-invasive marker of fibrosis and steatosis).&#xD;
The Prothrombin ratio is the ratio of a participants measured prothrombin time (in seconds) to the normal laboratory reference prothrombin time.&#xD;
Participants with missing data for Prothrombin ratio at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the &quot;Efficacy Evaluable Set&quot; of the Participant Flow.</description>
          <population>Efficacy evaluable set</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
                <count group_id="O2" value="76"/>
                <count group_id="O3" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.85" spread="11.57"/>
                    <measurement group_id="O2" value="1.29" spread="10.03"/>
                    <measurement group_id="O3" value="0.51" spread="14.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <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>0.075</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-2.83</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.95</ci_lower_limit>
            <ci_upper_limit>0.29</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.491</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-1.11</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.29</ci_lower_limit>
            <ci_upper_limit>2.07</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: International Normalized Ratio (INR)</title>
        <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in international normalized ratio (INR; non-invasive marker of fibrosis and steatosis).&#xD;
Participants with missing data for International Normalized Ratio (INR) at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the &quot;Efficacy Evaluable Set&quot; of the Participant Flow.</description>
        <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
        <population>Efficacy evaluable set</population>
        <group_list>
          <group group_id="O1">
            <title>GFT505 80mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration.&#xD;
3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.</description>
          </group>
          <group group_id="O2">
            <title>GFT505 120mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions.&#xD;
3 placebo capsules per day, before breakfast with a glass of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: International Normalized Ratio (INR)</title>
          <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in international normalized ratio (INR; non-invasive marker of fibrosis and steatosis).&#xD;
Participants with missing data for International Normalized Ratio (INR) at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the &quot;Efficacy Evaluable Set&quot; of the Participant Flow.</description>
          <population>Efficacy evaluable set</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
                <count group_id="O2" value="76"/>
                <count group_id="O3" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.03" spread="0.09"/>
                    <measurement group_id="O2" value="-0.01" spread="0.08"/>
                    <measurement group_id="O3" value="0.03" spread="0.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <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>0.393</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-0.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.1</ci_lower_limit>
            <ci_upper_limit>0.04</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.289</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-0.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.11</ci_lower_limit>
            <ci_upper_limit>0.03</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes From Baseline to Week 52 in Lipid Parameters (Cardiovascular Risk Profile)</title>
        <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to week 52, in lipid parameters (used to assess cardiovascular risk)</description>
        <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
        <population>Efficacy evaluable set</population>
        <group_list>
          <group group_id="O1">
            <title>GFT505 80mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration.&#xD;
3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.</description>
          </group>
          <group group_id="O2">
            <title>GFT505 120mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions.&#xD;
3 placebo capsules per day, before breakfast with a glass of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes From Baseline to Week 52 in Lipid Parameters (Cardiovascular Risk Profile)</title>
          <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to week 52, in lipid parameters (used to assess cardiovascular risk)</description>
          <population>Efficacy evaluable set</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Triglycerides</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="82"/>
                    <count group_id="O2" value="78"/>
                    <count group_id="O3" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.33" spread="0.76"/>
                    <measurement group_id="O2" value="-0.48" spread="0.90"/>
                    <measurement group_id="O3" value="0.16" spread="1.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cholesterol</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="82"/>
                    <count group_id="O2" value="78"/>
                    <count group_id="O3" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.42" spread="0.78"/>
                    <measurement group_id="O2" value="-0.42" spread="0.72"/>
                    <measurement group_id="O3" value="0.02" spread="0.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-high Density Lipoproteins Cholesterol</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="82"/>
                    <count group_id="O2" value="78"/>
                    <count group_id="O3" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.45" spread="0.79"/>
                    <measurement group_id="O2" value="-0.47" spread="0.71"/>
                    <measurement group_id="O3" value="0.07" spread="0.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>High Density Lipoproteins Cholesterol</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="82"/>
                    <count group_id="O2" value="78"/>
                    <count group_id="O3" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.02" spread="0.17"/>
                    <measurement group_id="O2" value="0.06" spread="0.23"/>
                    <measurement group_id="O3" value="-0.06" spread="0.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Very Low Density Lipoproteins Cholesterol</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="82"/>
                    <count group_id="O2" value="75"/>
                    <count group_id="O3" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.17" spread="0.28"/>
                    <measurement group_id="O2" value="-0.17" spread="0.32"/>
                    <measurement group_id="O3" value="0.05" spread="0.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Low Density Lipoproteins Cholesterol</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="82"/>
                    <count group_id="O2" value="75"/>
                    <count group_id="O3" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.27" spread="0.70"/>
                    <measurement group_id="O2" value="-0.25" spread="0.61"/>
                    <measurement group_id="O3" value="-0.01" spread="0.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Triglycerides</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-0.47</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.73</ci_lower_limit>
            <ci_upper_limit>-0.21</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Triglycerides</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-0.55</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.81</ci_lower_limit>
            <ci_upper_limit>-0.29</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Cholesterol</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-0.35</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.56</ci_lower_limit>
            <ci_upper_limit>-0.14</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Cholesterol</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-0.43</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.64</ci_lower_limit>
            <ci_upper_limit>-0.23</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Non-high Density Lipoproteins Cholesterol</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-0.46</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.67</ci_lower_limit>
            <ci_upper_limit>-0.24</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Non-high Density Lipoproteins Cholesterol</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-0.54</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.75</ci_lower_limit>
            <ci_upper_limit>-0.32</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>High Density Lipoproteins Cholesterol</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.005</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>0.09</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.03</ci_lower_limit>
            <ci_upper_limit>0.15</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>High Density Lipoproteins Cholesterol</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>0.11</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.05</ci_lower_limit>
            <ci_upper_limit>0.17</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Very Low Density Lipoproteins Cholesterol</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-0.18</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.26</ci_lower_limit>
            <ci_upper_limit>-0.11</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Very Low Density Lipoproteins Cholesterol</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-0.17</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.25</ci_lower_limit>
            <ci_upper_limit>-0.09</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Low Density Lipoproteins Cholesterol</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.031</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-0.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.38</ci_lower_limit>
            <ci_upper_limit>-0.02</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Low Density Lipoproteins Cholesterol</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.009</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-0.24</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.42</ci_lower_limit>
            <ci_upper_limit>-0.06</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes From Baseline to Week 52 in Outcomes Related to Biochemistry</title>
        <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to week 52, in secondary outcomes related to biochemistry</description>
        <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
        <population>Efficacy evaluable set</population>
        <group_list>
          <group group_id="O1">
            <title>GFT505 80mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration.&#xD;
3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.</description>
          </group>
          <group group_id="O2">
            <title>GFT505 120mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions.&#xD;
3 placebo capsules per day, before breakfast with a glass of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes From Baseline to Week 52 in Outcomes Related to Biochemistry</title>
          <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to week 52, in secondary outcomes related to biochemistry</description>
          <population>Efficacy evaluable set</population>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Apo A1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="82"/>
                    <count group_id="O2" value="78"/>
                    <count group_id="O3" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.63" spread="15.59"/>
                    <measurement group_id="O2" value="2.85" spread="20.42"/>
                    <measurement group_id="O3" value="-3.90" spread="16.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Apo B</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="82"/>
                    <count group_id="O2" value="78"/>
                    <count group_id="O3" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.80" spread="20.87"/>
                    <measurement group_id="O2" value="-8.42" spread="16.03"/>
                    <measurement group_id="O3" value="0.94" spread="14.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Apo AII</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="66"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.15" spread="6.63"/>
                    <measurement group_id="O2" value="4.25" spread="4.36"/>
                    <measurement group_id="O3" value="-3.36" spread="4.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Apo CIII</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="66"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.79" spread="3.91"/>
                    <measurement group_id="O2" value="-0.69" spread="3.42"/>
                    <measurement group_id="O3" value="0.77" spread="4.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Apo CIII/B</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="66"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.44" spread="2.98"/>
                    <measurement group_id="O2" value="-0.65" spread="2.98"/>
                    <measurement group_id="O3" value="0.53" spread="3.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Apo CIII/nonB</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="66"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.35" spread="1.79"/>
                    <measurement group_id="O2" value="-0.04" spread="0.76"/>
                    <measurement group_id="O3" value="0.24" spread="2.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Small dense Low Density Lipoproteins</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="71"/>
                    <count group_id="O2" value="69"/>
                    <count group_id="O3" value="69"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.09" spread="11.02"/>
                    <measurement group_id="O2" value="-2.62" spread="6.08"/>
                    <measurement group_id="O3" value="0.60" spread="7.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lp(a)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="66"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.57" spread="12.24"/>
                    <measurement group_id="O2" value="-0.91" spread="13.75"/>
                    <measurement group_id="O3" value="0.80" spread="4.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Apo E</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="66"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.72" spread="2.75"/>
                    <measurement group_id="O2" value="-1.38" spread="2.99"/>
                    <measurement group_id="O3" value="-0.29" spread="3.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Apo E/B</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="66"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.43" spread="2.43"/>
                    <measurement group_id="O2" value="-1.48" spread="2.64"/>
                    <measurement group_id="O3" value="-0.21" spread="2.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Apo A1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.038</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>5.73</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.31</ci_lower_limit>
            <ci_upper_limit>11.14</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Apo A1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.012</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>7.07</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.59</ci_lower_limit>
            <ci_upper_limit>12.55</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Apo B</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-12.41</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-17.56</ci_lower_limit>
            <ci_upper_limit>-7.25</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Apo B</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-9.61</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-14.81</ci_lower_limit>
            <ci_upper_limit>-4.41</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Apo AII</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>3.55</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.14</ci_lower_limit>
            <ci_upper_limit>4.96</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Apo AII</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>6.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>4.67</ci_lower_limit>
            <ci_upper_limit>7.53</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Apo CIII</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-2.27</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.29</ci_lower_limit>
            <ci_upper_limit>-1.25</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Apo CIII</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.004</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-1.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.52</ci_lower_limit>
            <ci_upper_limit>-0.49</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Apo CIII/B</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-1.78</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.63</ci_lower_limit>
            <ci_upper_limit>-0.92</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Apo CIII/B</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.009</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-1.15</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2</ci_lower_limit>
            <ci_upper_limit>-0.29</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Apo CIII/nonB</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.002</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-0.46</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.75</ci_lower_limit>
            <ci_upper_limit>-0.17</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Apo CIII/nonB</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.008</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-0.39</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.68</ci_lower_limit>
            <ci_upper_limit>-0.1</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Small dense Low Density Lipoproteins</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.069</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-2.35</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.89</ci_lower_limit>
            <ci_upper_limit>0.19</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Small dense Low Density Lipoproteins</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.01</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-3.39</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.95</ci_lower_limit>
            <ci_upper_limit>-0.84</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Lp(a)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.549</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>0.84</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.93</ci_lower_limit>
            <ci_upper_limit>3.61</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Lp(a)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.728</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>0.49</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.28</ci_lower_limit>
            <ci_upper_limit>3.26</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Apo E</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-1.38</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.14</ci_lower_limit>
            <ci_upper_limit>-0.61</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Apo E</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.004</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-1.12</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.89</ci_lower_limit>
            <ci_upper_limit>-0.36</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Apo E/B</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-1.18</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.82</ci_lower_limit>
            <ci_upper_limit>-0.53</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Apo E/B</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-1.08</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.72</ci_lower_limit>
            <ci_upper_limit>-0.43</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes From Baseline to Week 52 in Insulin Resistance: Leptin</title>
        <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in leptin (to assess insulin resistance).</description>
        <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
        <population>Efficacy evaluable set</population>
        <group_list>
          <group group_id="O1">
            <title>GFT505 80mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration.&#xD;
3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.</description>
          </group>
          <group group_id="O2">
            <title>GFT505 120mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions.&#xD;
3 placebo capsules per day, before breakfast with a glass of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes From Baseline to Week 52 in Insulin Resistance: Leptin</title>
          <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in leptin (to assess insulin resistance).</description>
          <population>Efficacy evaluable set</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.21" spread="9.55"/>
                    <measurement group_id="O2" value="3.51" spread="10.67"/>
                    <measurement group_id="O3" value="3.01" spread="8.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <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>0.066</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-2.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.79</ci_lower_limit>
            <ci_upper_limit>0.18</ci_upper_limit>
            <estimate_desc>Least square mean changes from baseline</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.615</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>0.77</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.24</ci_lower_limit>
            <ci_upper_limit>3.77</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes From Baseline to Week 52 in Insulin Resistance: Insulin</title>
        <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in insulin (to assess insulin resistance).&#xD;
Participants with missing data for Insulin at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the &quot;Efficacy Evaluable Set&quot; of the Participant Flow.</description>
        <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
        <population>Efficacy evaluable set</population>
        <group_list>
          <group group_id="O1">
            <title>GFT505 80mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration.&#xD;
3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.</description>
          </group>
          <group group_id="O2">
            <title>GFT505 120mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions.&#xD;
3 placebo capsules per day, before breakfast with a glass of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes From Baseline to Week 52 in Insulin Resistance: Insulin</title>
          <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in insulin (to assess insulin resistance).&#xD;
Participants with missing data for Insulin at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the &quot;Efficacy Evaluable Set&quot; of the Participant Flow.</description>
          <population>Efficacy evaluable set</population>
          <units>pmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-33.88" spread="189.64"/>
                    <measurement group_id="O2" value="-26.12" spread="111.76"/>
                    <measurement group_id="O3" value="8.92" spread="112.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <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>0.307</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-17.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-50.88</ci_lower_limit>
            <ci_upper_limit>16.08</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </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>0.213</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-21.41</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-55.17</ci_lower_limit>
            <ci_upper_limit>12.34</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes From Baseline to Week 52 in Insulin Resistance: C Peptide</title>
        <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in C peptide (to assess insulin resistance).&#xD;
Participants with missing data for C Peptide at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the &quot;Efficacy Evaluable Set&quot; of the Participant Flow.</description>
        <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
        <population>Efficacy evaluable set</population>
        <group_list>
          <group group_id="O1">
            <title>GFT505 80mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration.&#xD;
3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.</description>
          </group>
          <group group_id="O2">
            <title>GFT505 120mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions.&#xD;
3 placebo capsules per day, before breakfast with a glass of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes From Baseline to Week 52 in Insulin Resistance: C Peptide</title>
          <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in C peptide (to assess insulin resistance).&#xD;
Participants with missing data for C Peptide at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the &quot;Efficacy Evaluable Set&quot; of the Participant Flow.</description>
          <population>Efficacy evaluable set</population>
          <units>nmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
                <count group_id="O2" value="77"/>
                <count group_id="O3" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.17" spread="0.55"/>
                    <measurement group_id="O2" value="-0.03" spread="0.48"/>
                    <measurement group_id="O3" value="0.12" spread="0.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <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>0.003</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-0.23</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.37</ci_lower_limit>
            <ci_upper_limit>-0.08</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.068</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-0.14</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.29</ci_lower_limit>
            <ci_upper_limit>0.01</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes From Baseline to Week 52 in Insulin Resistance: Homeostatic Model Assessment-insulin Resistance (HOMA-IR)</title>
        <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in homeostatic model assessment-insulin resistance (HOMA-IR; to assess insulin resistance).&#xD;
The HOMA-IR is expressed as the following: HOMA-IR = fasting serum insulin (μU/ml) x fasting plasma glucose (mmol/l) / 22.5&#xD;
A decrease in HOMA-IR indicates a positive outcome. HOMA-IR values of greater than 1.9 indicates early insulin resistance and levels above 2.9 indicate significant insulin resistance.&#xD;
Participants with missing data for HOMA-IR at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the &quot;Efficacy Evaluable Set&quot; of the Participant Flow.</description>
        <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
        <population>Efficacy evaluable set</population>
        <group_list>
          <group group_id="O1">
            <title>GFT505 80mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration.&#xD;
3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.</description>
          </group>
          <group group_id="O2">
            <title>GFT505 120mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions.&#xD;
3 placebo capsules per day, before breakfast with a glass of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes From Baseline to Week 52 in Insulin Resistance: Homeostatic Model Assessment-insulin Resistance (HOMA-IR)</title>
          <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in homeostatic model assessment-insulin resistance (HOMA-IR; to assess insulin resistance).&#xD;
The HOMA-IR is expressed as the following: HOMA-IR = fasting serum insulin (μU/ml) x fasting plasma glucose (mmol/l) / 22.5&#xD;
A decrease in HOMA-IR indicates a positive outcome. HOMA-IR values of greater than 1.9 indicates early insulin resistance and levels above 2.9 indicate significant insulin resistance.&#xD;
Participants with missing data for HOMA-IR at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the &quot;Efficacy Evaluable Set&quot; of the Participant Flow.</description>
          <population>Efficacy evaluable set</population>
          <units>HOMA-IR score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.10" spread="10.76"/>
                    <measurement group_id="O2" value="-1" spread="6.86"/>
                    <measurement group_id="O3" value="1.01" spread="4.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <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>0.448</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-0.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.86</ci_lower_limit>
            <ci_upper_limit>1.27</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.267</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-1.17</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.25</ci_lower_limit>
            <ci_upper_limit>0.9</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes From Baseline to Week 52 in Insulin Resistance: Free Fatty Acids (FFA)</title>
        <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in free fatty acids (FFA; to assess insulin resistance).&#xD;
Participants with missing data for Free Fatty Acids (FFA) at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the &quot;Efficacy Evaluable Set&quot; of the Participant Flow.</description>
        <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
        <population>Efficacy evaluable set</population>
        <group_list>
          <group group_id="O1">
            <title>GFT505 80mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration.&#xD;
3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.</description>
          </group>
          <group group_id="O2">
            <title>GFT505 120mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions.&#xD;
3 placebo capsules per day, before breakfast with a glass of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes From Baseline to Week 52 in Insulin Resistance: Free Fatty Acids (FFA)</title>
          <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in free fatty acids (FFA; to assess insulin resistance).&#xD;
Participants with missing data for Free Fatty Acids (FFA) at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the &quot;Efficacy Evaluable Set&quot; of the Participant Flow.</description>
          <population>Efficacy evaluable set</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="78"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.04" spread="0.25"/>
                    <measurement group_id="O2" value="-0.04" spread="0.24"/>
                    <measurement group_id="O3" value="0.05" spread="0.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <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>0.095</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-0.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.11</ci_lower_limit>
            <ci_upper_limit>0.01</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.022</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-0.07</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.13</ci_lower_limit>
            <ci_upper_limit>-0.01</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes From Baseline to Week 52 in Insulin Resistance: Plasma Glucose</title>
        <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in plasma glucose (to assess insulin resistance).&#xD;
Participants with missing data for Plasma Glucose at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the &quot;Efficacy Evaluable Set&quot; of the Participant Flow.</description>
        <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
        <population>Efficacy evaluable set</population>
        <group_list>
          <group group_id="O1">
            <title>GFT505 80mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration.&#xD;
3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.</description>
          </group>
          <group group_id="O2">
            <title>GFT505 120mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions.&#xD;
3 placebo capsules per day, before breakfast with a glass of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes From Baseline to Week 52 in Insulin Resistance: Plasma Glucose</title>
          <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in plasma glucose (to assess insulin resistance).&#xD;
Participants with missing data for Plasma Glucose at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the &quot;Efficacy Evaluable Set&quot; of the Participant Flow.</description>
          <population>Efficacy evaluable set</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.17" spread="1.23"/>
                    <measurement group_id="O2" value="0.22" spread="1.70"/>
                    <measurement group_id="O3" value="0.67" spread="1.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <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>0.077</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-0.46</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.96</ci_lower_limit>
            <ci_upper_limit>0.05</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </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>0.172</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-0.36</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.87</ci_lower_limit>
            <ci_upper_limit>0.16</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes From Baseline to Week 52 in Insulin Resistance: Glycosylated Haemoglobin A1c (HbA1c)</title>
        <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in glycosylated haemoglobin A1c (HbA1c; to assess insulin resistance).&#xD;
Participants with missing data for Haemoglobin A1c (HbA1c) at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the &quot;Efficacy Evaluable Set&quot; of the Participant Flow.</description>
        <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
        <population>Efficacy evaluable set</population>
        <group_list>
          <group group_id="O1">
            <title>GFT505 80mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration.&#xD;
3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.</description>
          </group>
          <group group_id="O2">
            <title>GFT505 120mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions.&#xD;
3 placebo capsules per day, before breakfast with a glass of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes From Baseline to Week 52 in Insulin Resistance: Glycosylated Haemoglobin A1c (HbA1c)</title>
          <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in glycosylated haemoglobin A1c (HbA1c; to assess insulin resistance).&#xD;
Participants with missing data for Haemoglobin A1c (HbA1c) at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the &quot;Efficacy Evaluable Set&quot; of the Participant Flow.</description>
          <population>Efficacy evaluable set</population>
          <units>percentage of HbA1c</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
                <count group_id="O2" value="77"/>
                <count group_id="O3" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.22" spread="0.56"/>
                    <measurement group_id="O2" value="0.03" spread="0.70"/>
                    <measurement group_id="O3" value="0.25" spread="0.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <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>0.732</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-0.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.24</ci_lower_limit>
            <ci_upper_limit>0.17</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.062</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-0.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.4</ci_lower_limit>
            <ci_upper_limit>0.01</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes From Baseline to Week 52 in Insulin Resistance: Fructosamine</title>
        <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in Fructosamine (to assess insulin resistance).</description>
        <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
        <population>Efficacy evaluable set</population>
        <group_list>
          <group group_id="O1">
            <title>GFT505 80mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration.&#xD;
3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.</description>
          </group>
          <group group_id="O2">
            <title>GFT505 120mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions.&#xD;
3 placebo capsules per day, before breakfast with a glass of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes From Baseline to Week 52 in Insulin Resistance: Fructosamine</title>
          <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in Fructosamine (to assess insulin resistance).</description>
          <population>Efficacy evaluable set</population>
          <units>umol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.27" spread="27.53"/>
                    <measurement group_id="O2" value="-8.24" spread="28.21"/>
                    <measurement group_id="O3" value="11.29" spread="28.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <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>0.4</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>3.66</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.89</ci_lower_limit>
            <ci_upper_limit>12.2</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-16.22</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-24.99</ci_lower_limit>
            <ci_upper_limit>-7.44</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes From Baseline to Week 52 in Inflammatory Markers: Fibrinogen and Haptoglobin</title>
        <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to Week 52, in fibrinogen and haptoglobin (inflammatory markers).</description>
        <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
        <population>Efficacy evaluable set</population>
        <group_list>
          <group group_id="O1">
            <title>GFT505 80mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration.&#xD;
3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.</description>
          </group>
          <group group_id="O2">
            <title>GFT505 120mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions.&#xD;
3 placebo capsules per day, before breakfast with a glass of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes From Baseline to Week 52 in Inflammatory Markers: Fibrinogen and Haptoglobin</title>
          <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to Week 52, in fibrinogen and haptoglobin (inflammatory markers).</description>
          <population>Efficacy evaluable set</population>
          <units>g/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Fibrinogen</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="82"/>
                    <count group_id="O2" value="76"/>
                    <count group_id="O3" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.37" spread="0.70"/>
                    <measurement group_id="O2" value="-0.37" spread="0.79"/>
                    <measurement group_id="O3" value="-0.05" spread="0.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Haptoglobin</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.19" spread="0.32"/>
                    <measurement group_id="O2" value="-0.20" spread="0.40"/>
                    <measurement group_id="O3" value="0.09" spread="0.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Fibrinogen</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-0.36</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.54</ci_lower_limit>
            <ci_upper_limit>-0.17</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Fibrinogen</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.005</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-0.27</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.46</ci_lower_limit>
            <ci_upper_limit>-0.08</ci_upper_limit>
            <other_analysis_desc>Standard error of the least square mean</other_analysis_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Haptoglobin</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-0.25</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.35</ci_lower_limit>
            <ci_upper_limit>-0.15</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Haptoglobin</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-0.27</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.37</ci_lower_limit>
            <ci_upper_limit>-0.17</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes From Baseline to Week 52 in Inflammatory Markers: Tumour Necrosis Factor Alpha and Interleukine 6</title>
        <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to Week 52, in tumour necrosis factor alpha and interleukine 6 (inflammatory markers).</description>
        <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
        <population>Efficacy evaluable set</population>
        <group_list>
          <group group_id="O1">
            <title>GFT505 80mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration.&#xD;
3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.</description>
          </group>
          <group group_id="O2">
            <title>GFT505 120mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions.&#xD;
3 placebo capsules per day, before breakfast with a glass of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes From Baseline to Week 52 in Inflammatory Markers: Tumour Necrosis Factor Alpha and Interleukine 6</title>
          <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to Week 52, in tumour necrosis factor alpha and interleukine 6 (inflammatory markers).</description>
          <population>Efficacy evaluable set</population>
          <units>pg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Tumour Necrosis Factor alpha</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="78"/>
                    <count group_id="O3" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.37" spread="6.14"/>
                    <measurement group_id="O2" value="-2.45" spread="38.58"/>
                    <measurement group_id="O3" value="0.19" spread="10.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Interleukine 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="82"/>
                    <count group_id="O2" value="78"/>
                    <count group_id="O3" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.37" spread="4.20"/>
                    <measurement group_id="O2" value="-1.14" spread="10.33"/>
                    <measurement group_id="O3" value="-0.06" spread="1.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Tumour Necrosis Factor alpha</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.742</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>0.57</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.9</ci_lower_limit>
            <ci_upper_limit>4.06</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Tumour Necrosis Factor alpha</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.107</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>2.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.63</ci_lower_limit>
            <ci_upper_limit>6.43</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Interleukine 6</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.362</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>0.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.58</ci_lower_limit>
            <ci_upper_limit>1.59</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Interleukine 6</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.894</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>0.07</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.03</ci_lower_limit>
            <ci_upper_limit>1.18</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes From Baseline to Week 52 in Inflammatory Markers: Plasminogen Activator Inhibitor 1 (PAI-1)</title>
        <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to Week 52, in plasminogen activator inhibitor 1 (PAI-1; inflammatory marker).&#xD;
Participants with missing data for Plasminogen Activator Inhibitor 1 (PAI-1) at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the &quot;Efficacy Evaluable Set&quot; of the Participant Flow</description>
        <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
        <population>Efficacy evaluable set</population>
        <group_list>
          <group group_id="O1">
            <title>GFT505 80mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration.&#xD;
3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.</description>
          </group>
          <group group_id="O2">
            <title>GFT505 120mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions.&#xD;
3 placebo capsules per day, before breakfast with a glass of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes From Baseline to Week 52 in Inflammatory Markers: Plasminogen Activator Inhibitor 1 (PAI-1)</title>
          <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to Week 52, in plasminogen activator inhibitor 1 (PAI-1; inflammatory marker).&#xD;
Participants with missing data for Plasminogen Activator Inhibitor 1 (PAI-1) at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the &quot;Efficacy Evaluable Set&quot; of the Participant Flow</description>
          <population>Efficacy evaluable set</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="77"/>
                <count group_id="O3" value="66"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.51" spread="3.51"/>
                    <measurement group_id="O2" value="0.21" spread="4.28"/>
                    <measurement group_id="O3" value="-0.14" spread="4.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <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>0.229</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-0.76</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2</ci_lower_limit>
            <ci_upper_limit>0.48</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.463</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-0.45</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.67</ci_lower_limit>
            <ci_upper_limit>0.76</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes From Baseline to Week 52 in Inflammatory Markers: C-Reactive Protein (CRP)</title>
        <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to Week 52, in C-Reactive Protein (CRP; inflammatory marker).</description>
        <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
        <population>Efficacy evaluable set</population>
        <group_list>
          <group group_id="O1">
            <title>GFT505 80mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration.&#xD;
3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.</description>
          </group>
          <group group_id="O2">
            <title>GFT505 120mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions.&#xD;
3 placebo capsules per day, before breakfast with a glass of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes From Baseline to Week 52 in Inflammatory Markers: C-Reactive Protein (CRP)</title>
          <description>To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to Week 52, in C-Reactive Protein (CRP; inflammatory marker).</description>
          <population>Efficacy evaluable set</population>
          <units>Log (mg/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.04" spread="0.72"/>
                    <measurement group_id="O2" value="-0.05" spread="0.81"/>
                    <measurement group_id="O3" value="0.20" spread="0.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <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>0.065</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-0.21</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.42</ci_lower_limit>
            <ci_upper_limit>0.01</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.098</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-0.19</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.41</ci_lower_limit>
            <ci_upper_limit>0.03</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes From Baseline to Week 52 in Safety Markers: Creatinine (Renal Function Parameter)</title>
        <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in creatinine (safety markers; renal function parameter).</description>
        <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
        <population>Safety population</population>
        <group_list>
          <group group_id="O1">
            <title>GFT505 80mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration.&#xD;
3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.</description>
          </group>
          <group group_id="O2">
            <title>GFT505 120mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions.&#xD;
3 placebo capsules per day, before breakfast with a glass of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes From Baseline to Week 52 in Safety Markers: Creatinine (Renal Function Parameter)</title>
          <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in creatinine (safety markers; renal function parameter).</description>
          <population>Safety population</population>
          <units>μmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="93"/>
                <count group_id="O2" value="89"/>
                <count group_id="O3" value="92"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.03" spread="7.89"/>
                    <measurement group_id="O2" value="5.61" spread="8.18"/>
                    <measurement group_id="O3" value="1.27" spread="7.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <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>0.553</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>0.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.61</ci_lower_limit>
            <ci_upper_limit>3.01</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>4.31</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.97</ci_lower_limit>
            <ci_upper_limit>6.64</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes From Baseline to Week 52 in Safety Markers: Creatinine Clearance (Renal Function Parameter)</title>
        <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in creatinine clearance (safety marker; renal function parameter).</description>
        <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
        <population>Safety population</population>
        <group_list>
          <group group_id="O1">
            <title>GFT505 80mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration.&#xD;
3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.</description>
          </group>
          <group group_id="O2">
            <title>GFT505 120mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions.&#xD;
3 placebo capsules per day, before breakfast with a glass of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes From Baseline to Week 52 in Safety Markers: Creatinine Clearance (Renal Function Parameter)</title>
          <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in creatinine clearance (safety marker; renal function parameter).</description>
          <population>Safety population</population>
          <units>mL/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="93"/>
                <count group_id="O2" value="89"/>
                <count group_id="O3" value="92"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.06" spread="0.94"/>
                    <measurement group_id="O2" value="-0.56" spread="2.22"/>
                    <measurement group_id="O3" value="-0.09" spread="0.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <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>0.861</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>0.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.37</ci_lower_limit>
            <ci_upper_limit>0.44</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.052</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-0.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.81</ci_lower_limit>
            <ci_upper_limit>0</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes From Baseline to Week 52 in Safety Markers: Uric Acid (Renal Function Parameter)</title>
        <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in uric acid (safety marker; renal function parameter).</description>
        <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
        <population>Safety population</population>
        <group_list>
          <group group_id="O1">
            <title>GFT505 80mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration.&#xD;
3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.</description>
          </group>
          <group group_id="O2">
            <title>GFT505 120mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions.&#xD;
3 placebo capsules per day, before breakfast with a glass of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes From Baseline to Week 52 in Safety Markers: Uric Acid (Renal Function Parameter)</title>
          <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in uric acid (safety marker; renal function parameter).</description>
          <population>Safety population</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="93"/>
                <count group_id="O2" value="89"/>
                <count group_id="O3" value="92"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0.06"/>
                    <measurement group_id="O2" value="0.01" spread="0.05"/>
                    <measurement group_id="O3" value="-0.01" spread="0.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <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>0.473</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>0.01</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.01</ci_lower_limit>
            <ci_upper_limit>0.02</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.124</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>0.01</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0</ci_lower_limit>
            <ci_upper_limit>0.03</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes From Baseline to Week 52 in Safety Markers: Blood Urea Nitrogen (BUN; Renal Function Parameter)</title>
        <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in blood urea nitrogen (BUN; safety marker; renal function parameter).</description>
        <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
        <population>Safety population</population>
        <group_list>
          <group group_id="O1">
            <title>GFT505 80mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration.&#xD;
3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.</description>
          </group>
          <group group_id="O2">
            <title>GFT505 120mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions.&#xD;
3 placebo capsules per day, before breakfast with a glass of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes From Baseline to Week 52 in Safety Markers: Blood Urea Nitrogen (BUN; Renal Function Parameter)</title>
          <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in blood urea nitrogen (BUN; safety marker; renal function parameter).</description>
          <population>Safety population</population>
          <units>mmol urea/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="93"/>
                <count group_id="O2" value="89"/>
                <count group_id="O3" value="92"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.61" spread="1.28"/>
                    <measurement group_id="O2" value="0.67" spread="1.22"/>
                    <measurement group_id="O3" value="-0.17" spread="1.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>0.81</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.47</ci_lower_limit>
            <ci_upper_limit>1.15</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>0.85</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.5</ci_lower_limit>
            <ci_upper_limit>1.19</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes From Baseline to Week 52 in Safety Markers: Cystatin C (Renal Function Parameter)</title>
        <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in cystatin C (safety marker; renal function parameter).&#xD;
Participants with missing data for Cystatin C at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the &quot;Efficacy Evaluable Set&quot; of the Participant Flow.</description>
        <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
        <population>Safety population</population>
        <group_list>
          <group group_id="O1">
            <title>GFT505 80mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration.&#xD;
3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.</description>
          </group>
          <group group_id="O2">
            <title>GFT505 120mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions.&#xD;
3 placebo capsules per day, before breakfast with a glass of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes From Baseline to Week 52 in Safety Markers: Cystatin C (Renal Function Parameter)</title>
          <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in cystatin C (safety marker; renal function parameter).&#xD;
Participants with missing data for Cystatin C at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the &quot;Efficacy Evaluable Set&quot; of the Participant Flow.</description>
          <population>Safety population</population>
          <units>mg/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="93"/>
                <count group_id="O2" value="87"/>
                <count group_id="O3" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.05" spread="0.10"/>
                    <measurement group_id="O2" value="0.04" spread="0.22"/>
                    <measurement group_id="O3" value="0.04" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <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>0.842</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.04</ci_lower_limit>
            <ci_upper_limit>0.04</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.589</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>0.01</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.03</ci_lower_limit>
            <ci_upper_limit>0.05</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes From Baseline to Week 52 in Safety Markers: Beta2-microglobulin (Renal Function Parameter)</title>
        <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in beta2-microglobulin (safety marker; renal function parameter).&#xD;
Participants with missing data for Beta2-microglobulin at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the &quot;Efficacy Evaluable Set&quot; of the Participant Flow.</description>
        <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
        <population>Safety population</population>
        <group_list>
          <group group_id="O1">
            <title>GFT505 80mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration.&#xD;
3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.</description>
          </group>
          <group group_id="O2">
            <title>GFT505 120mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions.&#xD;
3 placebo capsules per day, before breakfast with a glass of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes From Baseline to Week 52 in Safety Markers: Beta2-microglobulin (Renal Function Parameter)</title>
          <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in beta2-microglobulin (safety marker; renal function parameter).&#xD;
Participants with missing data for Beta2-microglobulin at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the &quot;Efficacy Evaluable Set&quot; of the Participant Flow.</description>
          <population>Safety population</population>
          <units>μg/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="93"/>
                <count group_id="O2" value="87"/>
                <count group_id="O3" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-22.26" spread="326.42"/>
                    <measurement group_id="O2" value="0.11" spread="466.43"/>
                    <measurement group_id="O3" value="-83.48" spread="279.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <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>0.325</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>48.93</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.73</ci_lower_limit>
            <ci_upper_limit>146.6</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.066</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>93.21</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.06</ci_lower_limit>
            <ci_upper_limit>192.49</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes From Baseline to Week 52 in Safety Markers: N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP; Cardiac Function Parameter)</title>
        <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in N-terminal prohormone of brain natriuretic peptide (NT-proBNP; safety marker; cardiac function parameter).&#xD;
Participants with missing data for NT-proBNP at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the &quot;Efficacy Evaluable Set&quot; of the Participant Flow.</description>
        <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
        <population>Safety population</population>
        <group_list>
          <group group_id="O1">
            <title>GFT505 80mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration.&#xD;
3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.</description>
          </group>
          <group group_id="O2">
            <title>GFT505 120mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions.&#xD;
3 placebo capsules per day, before breakfast with a glass of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes From Baseline to Week 52 in Safety Markers: N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP; Cardiac Function Parameter)</title>
          <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in N-terminal prohormone of brain natriuretic peptide (NT-proBNP; safety marker; cardiac function parameter).&#xD;
Participants with missing data for NT-proBNP at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the &quot;Efficacy Evaluable Set&quot; of the Participant Flow.</description>
          <population>Safety population</population>
          <units>pmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="93"/>
                <count group_id="O2" value="87"/>
                <count group_id="O3" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.54" spread="4.16"/>
                    <measurement group_id="O2" value="0.38" spread="4.81"/>
                    <measurement group_id="O3" value="-1.24" spread="5.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>2.41</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.1</ci_lower_limit>
            <ci_upper_limit>3.72</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.019</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>1.59</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.26</ci_lower_limit>
            <ci_upper_limit>2.91</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes From Baseline to Week 52 in Safety Markers: Troponin T (Cardiac Function Parameter)</title>
        <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in troponin T (safety marker; cardiac function parameter).&#xD;
Participants with missing data for Troponin T at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the &quot;Efficacy Evaluable Set&quot; of the Participant Flow.</description>
        <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
        <population>Safety population</population>
        <group_list>
          <group group_id="O1">
            <title>GFT505 80mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration.&#xD;
3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.</description>
          </group>
          <group group_id="O2">
            <title>GFT505 120mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions.&#xD;
3 placebo capsules per day, before breakfast with a glass of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes From Baseline to Week 52 in Safety Markers: Troponin T (Cardiac Function Parameter)</title>
          <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in troponin T (safety marker; cardiac function parameter).&#xD;
Participants with missing data for Troponin T at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the &quot;Efficacy Evaluable Set&quot; of the Participant Flow.</description>
          <population>Safety population</population>
          <units>μg/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
                <count group_id="O2" value="87"/>
                <count group_id="O3" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                    <measurement group_id="O3" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <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>0.447</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0</ci_lower_limit>
            <ci_upper_limit>0</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.758</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0</ci_lower_limit>
            <ci_upper_limit>0</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes From Baseline to Week 52 in Body Weight</title>
        <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in body weight.</description>
        <time_frame>Baseline (Visit 2; Week 0) to Visit 8 (Week 52)</time_frame>
        <population>Efficacy evaluable set (EES)</population>
        <group_list>
          <group group_id="O1">
            <title>GFT505 80mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration.&#xD;
3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.</description>
          </group>
          <group group_id="O2">
            <title>GFT505 120mg</title>
            <description>Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions.&#xD;
3 placebo capsules per day, before breakfast with a glass of water.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes From Baseline to Week 52 in Body Weight</title>
          <description>To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in body weight.</description>
          <population>Efficacy evaluable set (EES)</population>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.11" spread="3.61"/>
                    <measurement group_id="O2" value="-0.69" spread="4.09"/>
                    <measurement group_id="O3" value="-0.04" spread="3.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <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>0.942</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>-0.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.12</ci_lower_limit>
            <ci_upper_limit>1.04</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.304</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Baseline parameter value and presence of diabetes as random factors</method_desc>
            <param_type>Difference in least square mean change</param_type>
            <param_value>0.57</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.52</ci_lower_limit>
            <ci_upper_limit>1.66</ci_upper_limit>
            <estimate_desc>Standard error of the least square mean</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks.</time_frame>
      <desc>The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.</desc>
      <group_list>
        <group group_id="E1">
          <title>GFT505 80mg</title>
          <description>Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.</description>
        </group>
        <group group_id="E2">
          <title>GFT505 120mg</title>
          <description>Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.</description>
        </group>
        <group group_id="E3">
          <title>Placebo</title>
          <description>Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions.&#xD;
3 placebo capsules per day, before breakfast with a glass of water.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (17.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Pericarditis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Pancreatitis Acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Device breakage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Clostridium Difficile Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Ankle fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Overdose</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Radius fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Hepatic haematoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Diabetes ketoacidosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Lumbar spinal stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Bladder cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Oesophageal adenocarcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Parathyroid tumour benign</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Renal cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Breast cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Bladder transitional cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Ataxia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Muscle contractions involuntary</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Parkinson's disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Abortion spontaneous</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Depression suicidal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Psychotic disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Bladder diverticulum</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Benign prostatic hyperplasia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Sinus operation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Thyroidectomy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>4</frequency_threshold>
        <default_vocab>MedDRA (17.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="85" subjects_at_risk="93"/>
                <counts group_id="E2" subjects_affected="86" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="85" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="23" subjects_affected="18" subjects_at_risk="93"/>
                <counts group_id="E2" events="20" subjects_affected="17" subjects_at_risk="89"/>
                <counts group_id="E3" events="16" subjects_affected="14" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="14" subjects_affected="12" subjects_at_risk="93"/>
                <counts group_id="E2" events="11" subjects_affected="9" subjects_at_risk="89"/>
                <counts group_id="E3" events="15" subjects_affected="13" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="11" subjects_affected="9" subjects_at_risk="93"/>
                <counts group_id="E2" events="12" subjects_affected="11" subjects_at_risk="89"/>
                <counts group_id="E3" events="12" subjects_affected="11" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="17" subjects_affected="14" subjects_at_risk="93"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="89"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="93"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="89"/>
                <counts group_id="E3" events="12" subjects_affected="9" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="93"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="89"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="93"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="89"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="89"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="93"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="15" subjects_affected="13" subjects_at_risk="93"/>
                <counts group_id="E2" events="14" subjects_affected="12" subjects_at_risk="89"/>
                <counts group_id="E3" events="16" subjects_affected="14" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="93"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="89"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="10" subjects_affected="7" subjects_at_risk="93"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="6" subjects_affected="5" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="89"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="11" subjects_affected="10" subjects_at_risk="93"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="89"/>
                <counts group_id="E3" events="8" subjects_affected="8" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="13" subjects_affected="9" subjects_at_risk="93"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="89"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="12" subjects_affected="10" subjects_at_risk="93"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="89"/>
                <counts group_id="E3" events="6" subjects_affected="5" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="93"/>
                <counts group_id="E2" events="11" subjects_affected="9" subjects_at_risk="89"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="10" subjects_affected="6" subjects_at_risk="93"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="89"/>
                <counts group_id="E3" events="5" subjects_affected="3" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="89"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="93"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="93"/>
                <counts group_id="E2" events="11" subjects_affected="11" subjects_at_risk="89"/>
                <counts group_id="E3" events="11" subjects_affected="10" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" events="6" subjects_affected="4" subjects_at_risk="93"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="89"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="93"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="89"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Glycosylated haemoglobin increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="89"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="92"/>
              </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="7" subjects_affected="5" subjects_at_risk="93"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="89"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Hypertriglyceridaemia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="93"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="89"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="93"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="89"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="89"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Hyperlipidaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="93"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="9" subjects_affected="7" subjects_at_risk="93"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="89"/>
                <counts group_id="E3" events="9" subjects_affected="8" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="93"/>
                <counts group_id="E2" events="10" subjects_affected="9" subjects_at_risk="89"/>
                <counts group_id="E3" events="9" subjects_affected="6" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="93"/>
                <counts group_id="E2" events="5" subjects_affected="3" subjects_at_risk="89"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="93"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="89"/>
                <counts group_id="E3" events="7" subjects_affected="6" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="93"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="23" subjects_affected="16" subjects_at_risk="93"/>
                <counts group_id="E2" events="14" subjects_affected="12" subjects_at_risk="89"/>
                <counts group_id="E3" events="17" subjects_affected="15" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="12" subjects_affected="10" subjects_at_risk="93"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="89"/>
                <counts group_id="E3" events="9" subjects_affected="9" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="93"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="89"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="93"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="89"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Sleep disorder</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="93"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="89"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Leukocyturia</sub_title>
                <counts group_id="E1" events="12" subjects_affected="10" subjects_at_risk="93"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="89"/>
                <counts group_id="E3" events="17" subjects_affected="12" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Glycosuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="89"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="89"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Benign prostatic hyperplasia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="93"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="92"/>
              </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="2" subjects_affected="2" subjects_at_risk="93"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="89"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="8" subjects_affected="6" subjects_at_risk="93"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="89"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="93"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="89"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="93"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="89"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="93"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="89"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="93"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="89"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="92"/>
              </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>All materials, information (oral or written) and unpublished documentation provided to the Investigators (or any company/institution acting on their behalf) are the exclusive property of the Sponsor and may not be given or disclosed, either in part or in whole, by the Investigator or by any person under his/her authority to any third party without the prior express consent of the Sponsor.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Carol Addy, MD MMSc</name_or_title>
      <organization>GENFIT</organization>
      <phone>+01 6179536469</phone>
    </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/NCT01694849
org study id: GFT505-212-7
secondary id: 2012-000295-42
nct id: NCT01694849
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
Abdominal obesity and type-2 Diabetes are associated with chronic liver disorders resulting
      from the accumulation of fat in the liver (steatosis), which may progress towards hepatitis
      and possibly lead to cirrhosis and liver cancer. NAFLD (Non Alcoholic Fatty Liver Disease) is
      considered as the most common form of chronic liver disease in adults in the United States,
      Australia, Asia and Europe. In the USA, the estimated prevalence of NAFLD is 20-30% of the
      adult population.

      Non-alcoholic Steatohepatitis (NASH) is a progressing form of NAFLD, which corresponds to
      hepatic steatosis associated with inflammation and liver cell injury upon microscopic
      examination of a liver biopsy. This condition may lead to advanced fibrosis and cirrhosis and
      deserves serious medical management. Up to now, there is no effective drug which has clearly
      demonstrated therapeutic efficacy which may help lifestyle and dietary recommendations in the
      resolution of NASH.

      In this context, GENFIT is developing a new liver targeted drug candidate, GFT505, for the
      treatment of NASH and the reduction of multiple cardiometabolic risk factors associated with
      the metabolic syndrome and type 2 Diabetes.

      This phase IIb study will evaluate the efficacy and safety of GFT505 80mg and 120mg once
      daily for 52 weeks on the reversal of NASH without worsening of fibrosis, based on liver
      biopsy assessments.
The study duration per patient will be 80 weeks. A screening period (from 4 to 16 weeks) will
      precede a 52-week double-blind treatment period and a 3 months follow-up period.

      The study will be conducted in 270 patients (90 patients in the placebo arm, 90 patients in
      the GFT505 80mg arm, and 90 patients in the GFT505 120mg arm).

      Enrollment will be performed in two phases: during the first phase, the patients will receive
      either GFT505 at a dose of 80 mg either the placebo. An independent expert committee will
      review the safety data when 45 patients receiving the dose at 80 mg will have been treated
      for 6 months. The committee approval will be necessary to start the second phase, while the
      patients will receive either GFT505 at a dose of 80 mg, or GFT505 at a dose of 120 mg or the
      placebo.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percentage of Responders With Disappearance of Steatohepatitis Without Worsening of Fibrosis (ie, Participants no Longer Meeting the Criteria for Steatohepatitis)
time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
description: Percentage of responders from baseline to Week 52 defined by the disappearance of steatohepatitis (ie, participants no longer meeting the criteria for steatohepatitis) without worsening of fibrosis.
Worsening of fibrosis was evaluated using Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) fibrosis staging system and defined as:
Progression to stage 3 or 4 for participants at stage 0, 1 or 2 on diagnostic liver biopsy
Progression to stage 4 for participants at stage 3 on diagnostic liver biopsy
measure: Change From Baseline to Week 52 in Non-alcoholic Fatty Liver Disease Activity Score
time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
description: To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg the change from baseline to Week 52, in Non-alcoholic Fatty Liver Disease Activity Score (NAS score).
NAS score is a composite score equal to the sum of the steatosis grade (0 to 3), lobular inflammation grade (0 to 3) and hepatocellular ballooning grade (0 to 2). The overall scale of the NAS is 0 to 8, with higher scores indicating more severe disease. The outcome measure, change from baseline in NAFLD Activity Score (NAS), has a possible range from -8 to +8, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
measure: Number of Participants With Change From Baseline to Week 52 in Non-alcoholic Fatty Liver Disease Activity Score of at Least 2 Points
time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
description: To evaluate the number of participants with at least a 2 point decrease from baseline in Non-alcoholic Fatty Liver Disease Activity Score (NAS) after 52 weeks of daily administration of GFT505 80mg or 120mg. The NAS refers to the severity of ongoing liver injury as assessed by a liver biopsy and is used to assess the activity of the disease. It is based on the NASH CRN methodology for scoring the severity of steatosis (score of 0 to 3), inflammation (score of 0 to 3), and hepatocellular ballooning (score of 0 to 2), with a maximum score of 8. A total NAS score of five or greater correlates with the diagnosis of steatohepatitis.
In table below for raw "Mild (Nonalcoholic Fatty Liver Disease Activity Score 3)" and the column "GFT505 80mg" the result should be read as : 2 participants (out of 10 participants analysed with a baseline NAS at 3) had at Least 2 points decrease on their NAS after 52 weeks of daily administration of GFT505 80mg. It corresponds to 20% (2 out of 10).
measure: Number of Participants With Decrease in Steatosis Score of at Least 1 Point Between Baseline and Week 52
time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
description: To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, number of participants with a decrease in steatosis score of at least 1 point between baseline and Week 52.
Steatosis is assessed by a liver biopsy and evaluated on a scale of 0 to 3 with higher scores indicating more severe steatosis. A score of 0 indicating a lower severity with low parenchymal involvement (<5%), while a score of 3 is indicative of higher involvment/severity (> 66%).
In below table and for helping how results are reported, as an example for raw "Mild (Nonalcoholic Fatty Liver Disease Activity Score 3)" and the column "GFT505 80mg" the result should be read as : 1 participants (out of 10 participants analysed with a baseline NAS at 3) had at least 1 point decrease Steatosis Score after 52 weeks of daily administration of GFT505 80mg. It corresponds to 10% (1 out of 10).
measure: Number of Participants With Decrease in Lobular Inflammation Score of at Least 1 Point Between Baseline and Week 52
time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
description: To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, number of participants with a decrease in lobular inflammation score of at least 1 point between baseline and Week 52.
Lobular inflammation is assessed by a liver biopsy and evaluated on a scale of 0 to 3. A score of 0 indicating the absence of inflammation loci, while a score of 3 is indicative of a higher degree of inflammation with more than 4 inflammation loci 200 x field.
In below table and for helping how results are reported, as an example for raw "Mild (Nonalcoholic Fatty Liver Disease Activity Score 3)" and the column "GFT505 80mg" the result should be read as : 1 participants (out of 10 participants analysed with a baseline NAS at 3) had at least 1 point decrease of Lobular Inflammation Score after 52 weeks of daily administration of GFT505 80mg. It corresponds to 10% (1 out of 10).
measure: Title: Number of Participants With Decrease in Ballooning Score of at Least 1 Point Between Baseline and Week 52
time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
description: To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, number of participants with a decrease in ballooning score of at least 1 point between baseline and Week 52.
Ballooning is assessed by a liver biopsy and evaluated on a scale of 0 to 2 with higher scores indicating more severe ballooning (0: No ballooned cells, 1: Few [rare but definite] ballooned hepatocytes; 2: Many ballooned cells/prominent ballooning).
In below table and for helping how results are reported, as an example for raw "Mild (Nonalcoholic Fatty Liver Disease Activity Score 3)" and the column "GFT505 80mg" the result should be read as : 4 participants (out of 10 participants analysed with a baseline NAS at 3) had at least 1 point decrease of Ballooning Score after 52 weeks of daily administration of GFT505 80mg. It corresponds to 10% (1 out of 10).
measure: Changes From Baseline to Week 52 in the Stages of Fibrosis
time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
description: To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in stages of fibrosis (based on Non-Alcoholic Steatohepatitis Clinical Research Network [NASH CRN] scoring).
Fibrosis is assessed on a scale of 0 to 4 with higher scores indicating more severe fibrosis.
measure: Changes From Baseline to Visit 8 (Week 52) in Liver Enzymes
time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
description: To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to week 52, in liver enzymes.
measure: Changes From Baseline to Visit 8 (Week 52) in Aspartate Transaminase/Alanine Aminotransferase Ratio
time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
description: To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to week 52, in aspartate transaminase/alanine aminotransferase ratio
measure: Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: CK 18-M65
time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
description: To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in CK 18-M65 (non-invasive markers of fibrosis and steatosis).
measure: Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: CK18 M30
time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
description: To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in CK18 M30 (non-invasive markers of fibrosis and steatosis).
Participants with missing data for CK18 M30 at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.
measure: Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Adiponectin
time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
description: To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in adiponectin (non-invasive markers of fibrosis and steatosis).
measure: Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Ferritin
time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
description: To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in ferritin (non-invasive markers of fibrosis and steatosis).
Participants with missing data for Ferritin at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.
measure: Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: FG19 and FG21
time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
description: To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in FG19 and FG21 (non-invasive markers of fibrosis and steatosis).
measure: Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Alpha2 Macroglobulin
time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
description: To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in alpha2 macroglobulin (a non-invasive marker of fibrosis and steatosis).
Participants with missing data for Alpha2 Macroglobulin at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.
measure: Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Hyaluronic Acid, N-terminal Pro-peptide of Collagen Type III (PIIINP), and Tissue Inhibitor of Matrix Metalloprotease-1 (TIMP-1)
time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
description: To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in hyaluronic acid, N-terminal pro-peptide of collagen type III (PIIINP), and tissue inhibitor of matrix metalloprotease-1 (TIMP-1) (non-invasive markers of fibrosis and steatosis).
measure: Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Fibrotest
time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
description: Fibrotest combines α2-macroglobulin (a2m), apolipoprotein A1 (aA1), total bilirubin (BIL), haptoglobin (h), GGT, and ALT with adjustment for age and gender. Fibrotest is calculated as: z = 4.467 x log(a2m) - 1.357 x log(h) + 1.017 x log(GGT) + 0.0281 x Age + 1.737 x log(BIL) - 1.184 x (aA1) + 0.301 x Gender - 5.54 where Gender = 1 for male and Gender = 0 for female. The score is then: 1/(1+e^-z). Calculated score range from 0 (no fibrosis) to 1 (severe fibrosis or cirrhosis) In below table for "Fibrotest" and for column "GFT505 80mg" the result should be read as: the mean of change from baseline to week 52 of Fibrotest calculated in 81 participants is -0.06 with a standard deviation of 0.08.
measure: Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Steatotest
time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
description: SteatoTest combines α2-macroglobulin, haptoglobin, apolipoprotein A1, total bilirubin, GGT, fasting glucose, triglycerides, cholesterol, and ALT, adjusted for patient's age, sex, weight, and height. Patented formula. Calculated score range from 0 (no steatosis) to 1 (severe steatosis) In below table for "Steatotest" and for column "GFT505 80mg" the result should be read as: the mean of change from baseline to week 52 of Steatotest calculated in 81 participants is -0.09 with a standard deviation of 0.11.
measure: Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Angulo Index or Non-Alcoholic Fatty Liver Disease Fibrosis Score
time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
description: Angulo Index or Non-Alcoholic Fatty Liver Disease Fibrosis Score is based on age, hyperglycemia, BMI, platelet count, albumin level, and AST/ALT ratio. Score is calculated using the following formula: -1.675 + 0.037 × age (years) + 0.094 × BMI (kg/m^2) + 1.13 × IFG/diabetes (yes = 1, no = 0) + 0.99 × AST/ALT ratio - 0.013 × platelet (×10^9/l) - 0.66 × albumin (g/dl). A score of <-1.455 indicates no advanced fibrosis and a score of >0.676 indicates liver fibrosis.
In below table for "Angulo index" and for column "GFT505 80mg" the result should be read as: the mean of change from baseline to week 52 of Angulo index calculated in 82 participants is 0.06 with a standard deviation of 0.53.
measure: Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Enhanced Liver Fibrosis (ELF)
time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
description: Enhanced Liver Fibrosis (ELF) combines measurements of tissue inhibitor of metalloprotein-ases-1 (TIMP-1), amino-terminal propeptide of type III procollagen (PIIINP), and hyaluronic acid (HA) . The ELF score is calculated as : 2.278 + 0.851 ln (HA) + 0.751 ln (PIIINP) + 0.394 ln (TIMP-1). ELF score range from An ELF score of less than 7.7 indicates no fibrosis. An ELF score greater than or equal to 9.8 indicates severe fibrosis. An ELF score of 11.3 or greater indicates cirrhosis. A decrease in ELF score represents a positive outcome In below table for "Enhanced Liver Fibrosis" and for column "GFT505 80mg" the result should be read as : the mean of change from baseline to week 52 of Enhanced Liver Fibrosis calculated in 81 analysed participants is -0.01 with a standard deviation of 0.54.
measure: Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Fatty Liver Index (FLI)
time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
description: The Fatty Liver Index (FLI) combines triglycerides, BMI, GGT and Waist circumference. FLI is calculated as : (e0.953×loge[triglycerides]+0.139× Body Mass Index[BMI]+0.718×loge Gamma- Glutamyl Transferase [GGT]+0.053×waistcircumference-15.745)/ (1 +e0.953×loge[triglycerides]+0.139×BMI+0.718×loge [GGT]+0.053×waistcircumference-15.745) × 100. Calculated index range from 0 to 100. FLI score below 30 indicate absence of Fatty Liver and FLI Score of 60 and above indicates presence of Fatty Liver.
In below table for "Fatty Liver Index" and for column "GFT505 80mg" the result should be read as : the mean of change from baseline to week 52 of Fatty Liver Index calculated in 82 analysed participants is -7.94 with a standard deviation of 11.74.
measure: Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Fibrometer
time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
description: Fibrometer combines Platelets, AST, ALT, ferritin, glucose (fasting plasma), Weight and gender. Patented formula. Score ranges from 0 (no fibrosis) to 1 (severe fibrosis or cirrhosis) In below table for "Fibrometer" and for column "GFT505 80mg" the result should be read as : the mean of change from baseline to week 52 of Fibrometer calculated in 81 analysed participants is 0.04 with a standard deviation of 0.23.
measure: Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Total Bilirubin and Conjugated Bilirubin
time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
description: To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in total bilirubin and conjugated bilirubin (non-invasive markers of fibrosis and steatosis).
measure: Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Prothrombin Ratio
time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
description: To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in prothrombin ratio (non-invasive marker of fibrosis and steatosis).
The Prothrombin ratio is the ratio of a participants measured prothrombin time (in seconds) to the normal laboratory reference prothrombin time.
Participants with missing data for Prothrombin ratio at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.
measure: Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: International Normalized Ratio (INR)
time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
description: To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in international normalized ratio (INR; non-invasive marker of fibrosis and steatosis).
Participants with missing data for International Normalized Ratio (INR) at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.
measure: Changes From Baseline to Week 52 in Lipid Parameters (Cardiovascular Risk Profile)
time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
description: To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to week 52, in lipid parameters (used to assess cardiovascular risk)
measure: Changes From Baseline to Week 52 in Outcomes Related to Biochemistry
time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
description: To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to week 52, in secondary outcomes related to biochemistry
measure: Changes From Baseline to Week 52 in Insulin Resistance: Leptin
time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
description: To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in leptin (to assess insulin resistance).
measure: Changes From Baseline to Week 52 in Insulin Resistance: Insulin
time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
description: To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in insulin (to assess insulin resistance).
Participants with missing data for Insulin at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.
measure: Changes From Baseline to Week 52 in Insulin Resistance: C Peptide
time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
description: To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in C peptide (to assess insulin resistance).
Participants with missing data for C Peptide at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.
measure: Changes From Baseline to Week 52 in Insulin Resistance: Homeostatic Model Assessment-insulin Resistance (HOMA-IR)
time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
description: To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in homeostatic model assessment-insulin resistance (HOMA-IR; to assess insulin resistance).
The HOMA-IR is expressed as the following: HOMA-IR = fasting serum insulin (μU/ml) x fasting plasma glucose (mmol/l) / 22.5
A decrease in HOMA-IR indicates a positive outcome. HOMA-IR values of greater than 1.9 indicates early insulin resistance and levels above 2.9 indicate significant insulin resistance.
Participants with missing data for HOMA-IR at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.
measure: Changes From Baseline to Week 52 in Insulin Resistance: Free Fatty Acids (FFA)
time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
description: To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in free fatty acids (FFA; to assess insulin resistance).
Participants with missing data for Free Fatty Acids (FFA) at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.
measure: Changes From Baseline to Week 52 in Insulin Resistance: Plasma Glucose
time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
description: To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in plasma glucose (to assess insulin resistance).
Participants with missing data for Plasma Glucose at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.
measure: Changes From Baseline to Week 52 in Insulin Resistance: Glycosylated Haemoglobin A1c (HbA1c)
time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
description: To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in glycosylated haemoglobin A1c (HbA1c; to assess insulin resistance).
Participants with missing data for Haemoglobin A1c (HbA1c) at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.
measure: Changes From Baseline to Week 52 in Insulin Resistance: Fructosamine
time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
description: To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in Fructosamine (to assess insulin resistance).
measure: Changes From Baseline to Week 52 in Inflammatory Markers: Fibrinogen and Haptoglobin
time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
description: To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to Week 52, in fibrinogen and haptoglobin (inflammatory markers).
measure: Changes From Baseline to Week 52 in Inflammatory Markers: Tumour Necrosis Factor Alpha and Interleukine 6
time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
description: To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to Week 52, in tumour necrosis factor alpha and interleukine 6 (inflammatory markers).
measure: Changes From Baseline to Week 52 in Inflammatory Markers: Plasminogen Activator Inhibitor 1 (PAI-1)
time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
description: To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to Week 52, in plasminogen activator inhibitor 1 (PAI-1; inflammatory marker).
Participants with missing data for Plasminogen Activator Inhibitor 1 (PAI-1) at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow
measure: Changes From Baseline to Week 52 in Inflammatory Markers: C-Reactive Protein (CRP)
time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
description: To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to Week 52, in C-Reactive Protein (CRP; inflammatory marker).
measure: Changes From Baseline to Week 52 in Safety Markers: Creatinine (Renal Function Parameter)
time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
description: To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in creatinine (safety markers; renal function parameter).
measure: Changes From Baseline to Week 52 in Safety Markers: Creatinine Clearance (Renal Function Parameter)
time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
description: To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in creatinine clearance (safety marker; renal function parameter).
measure: Changes From Baseline to Week 52 in Safety Markers: Uric Acid (Renal Function Parameter)
time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
description: To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in uric acid (safety marker; renal function parameter).
measure: Changes From Baseline to Week 52 in Safety Markers: Blood Urea Nitrogen (BUN; Renal Function Parameter)
time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
description: To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in blood urea nitrogen (BUN; safety marker; renal function parameter).
measure: Changes From Baseline to Week 52 in Safety Markers: Cystatin C (Renal Function Parameter)
time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
description: To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in cystatin C (safety marker; renal function parameter).
Participants with missing data for Cystatin C at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.
measure: Changes From Baseline to Week 52 in Safety Markers: Beta2-microglobulin (Renal Function Parameter)
time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
description: To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in beta2-microglobulin (safety marker; renal function parameter).
Participants with missing data for Beta2-microglobulin at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.
measure: Changes From Baseline to Week 52 in Safety Markers: N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP; Cardiac Function Parameter)
time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
description: To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in N-terminal prohormone of brain natriuretic peptide (NT-proBNP; safety marker; cardiac function parameter).
Participants with missing data for NT-proBNP at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.
measure: Changes From Baseline to Week 52 in Safety Markers: Troponin T (Cardiac Function Parameter)
time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
description: To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in troponin T (safety marker; cardiac function parameter).
Participants with missing data for Troponin T at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.
measure: Changes From Baseline to Week 52 in Body Weight
time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
description: To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in body weight.
arm group label: GFT505 80mg
arm group type: Experimental
description: Hard gelatin capsules dosed at 40mg, oral administration, 3 capsules per day before breakfast with a glass of water.
arm group label: GFT505 120mg
arm group type: Experimental
description: Hard gelatin capsules dosed at 40mg, oral administration, 3 capsules per day before breakfast with a glass of water.
arm group label: Placebo
arm group type: Placebo Comparator
description: hard gelatin capsules, oral administration, 3 capsules per day before breakfast with a glass of water.
intervention type: Drug
intervention name: GFT505 80mg
arm group label: GFT505 80mg
intervention type: Drug
intervention name: GFT505 120mg
arm group label: GFT505 120mg
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Rémy HANF, PhD
role: Study Director
affiliation: Development Director Genfit, France
last name: Pr. Vlad RATZIU, M.D.
role: Study Chair
affiliation: International Coordinator - La Pitié-Salpêtrière Hospital - Paris 13, France
last name: Pr. Arun SANYAL, M.D.
role: Principal Investigator
affiliation: National Coordinator -Virginia Commonwealth University - Richmond - USA
last name: Dr. Sven FRANCQUE, M.D.
role: Principal Investigator
affiliation: National Coordinator - UZA - Edegem - Belgium
last name: Dr. Jost PH DRENTH, MD, Ph.D
role: Principal Investigator
affiliation: National Coordinator - UMC St Radboud Nijmegen - Nijmegen - The Netherlands
last name: Pr. Michael Manns, M.D.
role: Principal Investigator
affiliation: National Coordinator - Medical School of Hannover - Hannover - Germany
last name: Pr. Elisabetha BUGIANESI, M.D.
role: Principal Investigator
affiliation: National Coordinator - University of Torino - S. Giovanni Battista Hospital - Torino - Italy
last name: Pr. Mihai VOICULESCU, M.D.
role: Principal Investigator
affiliation: National Coordinator - Center of Internal Medicine, Fundeni Clinical Institute - Bucharest - Romania
last name: Pr. Manuel ROMERO-GOMEZ, M.D.
role: Principal Investigator
affiliation: National Coordinator - Valme University hospital - Sevilla - Spain
last name: Pr. Quentin M. ANSTEE, M.D.
role: Principal Investigator
affiliation: National Coordinator - Freeman Hospital - Newcastle - UK
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: France
country: Germany
country: Italy
country: Netherlands
country: Romania
country: Spain
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Fatty Liver
mesh term: Non-alcoholic Fatty Liver Disease
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 