<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/NCT01672866</url>
  </required_header>
  <id_info>
    <org_study_id>GS-US-321-0105</org_study_id>
    <secondary_id>2012-002488-88</secondary_id>
    <nct_id>NCT01672866</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Simtuzumab (SIM, GS-6624) in Adults With Advanced Liver Fibrosis But Not Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)</brief_title>
  <official_title>A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of GS-6624, a Monoclonal Antibody Against Lysyl Oxidase-Like Molecule 2 (LOXL2), in Subjects With Advanced Liver Fibrosis But Not Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gilead Sciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gilead Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to evaluate whether SIM (formerly referred to as&#xD;
      GS-6624) is effective at preventing the histologic progression of liver fibrosis and the&#xD;
      clinical progression to cirrhosis in participants with NASH.&#xD;
&#xD;
      It will consist of 2 phases:&#xD;
&#xD;
        -  Randomized Double-Blind Phase&#xD;
&#xD;
        -  Open-Label Phase (optional)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date type="Actual">December 5, 2012</start_date>
  <completion_date type="Actual">December 29, 2016</completion_date>
  <primary_completion_date type="Actual">August 2, 2016</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in MQC on Liver Biopsy</measure>
    <time_frame>Baseline to Week 96</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Event Free Survival (EFS) Using Kaplan-Meier</measure>
    <time_frame>Baseline up to the time of progression to cirrhosis or last dose date (maximum: 240 weeks in the Blinded Phase), which ever occurred first</time_frame>
    <description>The EFS was the primary clinical efficacy endpoint and was assessed by the time to progression to cirrhosis. Participants were considered to have become cirrhotic if they had a post-baseline biopsy consistent with cirrhosis or developed overt signs and symptoms of cirrhosis. All overt signs and symptoms went through an adjudication process and were confirmed before they were considered for the EFS analysis.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">222</enrollment>
  <condition>Liver Fibrosis Due to NASH</condition>
  <arm_group>
    <arm_group_label>SIM 75 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>During the Randomized Double-Blind Phase, participants will receive SIM 75 mg via subcutaneous injection once weekly for up to 240 weeks. During the optional Open-Label Phase, participants will receive SIM 125 mg via subcutaneous injection once weekly for up to an additional 240 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SIM 125 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>During the Randomized Double-Blind Phase, participants will receive SIM 125 mg via subcutaneous injection once weekly for up to 240 weeks. During the optional Open-Label Phase, participants will receive SIM 125 mg via subcutaneous injection once weekly for up to an additional 240 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>During the Randomized Double-Blind Phase, participants will receive placebo to match SIM via subcutaneous injection once weekly for up to 240 weeks. During the optional Open-Label Phase, participants will receive SIM 125 mg via subcutaneous injection once weekly for up to an additional 240 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo to match SIM via subcutaneous injection every week</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>SIM</intervention_name>
    <description>Subcutaneous injection every week</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>SIM 125 mg</arm_group_label>
    <arm_group_label>SIM 75 mg</arm_group_label>
    <other_name>GS-6624</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Adults with chronic liver disease due to NASH defined as macrovesicular steatosis&#xD;
             involving &gt; 5% of hepatocytes on a liver biopsy with associated lobular inflammation&#xD;
&#xD;
          -  Stage 3-4 fibrosis by Ishak score on a liver biopsy&#xD;
&#xD;
          -  Exclusion of other causes of liver disease including viral hepatitis and alcoholic&#xD;
             liver disease&#xD;
&#xD;
          -  Must have aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 10 x&#xD;
             Central Laboratory Upper Limit of Normal (clULN)&#xD;
&#xD;
          -  Must have serum creatinine &lt; 2.0 mg/dL&#xD;
&#xD;
          -  A negative serum pregnancy test is required for females of childbearing potential&#xD;
&#xD;
          -  All sexually active females of childbearing potential must agree to use a protocol&#xD;
             recommended method of contraception during intercourse throughout the study and for 90&#xD;
             days following the last dose of study medication&#xD;
&#xD;
          -  Lactating females must agree to discontinue nursing before starting study treatment&#xD;
&#xD;
          -  Males, if not vasectomized, are required to use barrier contraception (condom plus&#xD;
             spermicide) during heterosexual intercourse from the screening through the study&#xD;
             completion and for 90 days following the last dose of study drug.&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breast feeding&#xD;
&#xD;
          -  Cirrhosis of the liver&#xD;
&#xD;
          -  Any history of hepatic decompensation including ascites, hepatic encephalopathy or&#xD;
             variceal bleeding&#xD;
&#xD;
          -  Weight reduction surgery in the past 5 years&#xD;
&#xD;
          -  Positive for hepatitis C virus (HCV) RNA&#xD;
&#xD;
          -  Positive for HBsAg&#xD;
&#xD;
          -  Alcohol consumption greater than 21oz/week for males or 14oz/week for females&#xD;
&#xD;
          -  Positive urine screen for amphetamines, cocaine or opiates (i.e. heroin, morphine) at&#xD;
             screening.&#xD;
&#xD;
          -  Clinically significant cardiac disease&#xD;
&#xD;
          -  History of malignancy, other than non-melanomatous skin cancer, within 5 years prior&#xD;
             to screening&#xD;
&#xD;
          -  Major surgical procedure within 30 days prior to screening or the presence of an open&#xD;
             wound&#xD;
&#xD;
          -  Known hypersensitivity to the investigation product or any of its formulation&#xD;
             excipients&#xD;
&#xD;
          -  History of bleeding diathesis within 6 months of screening&#xD;
&#xD;
          -  Unavailable for follow-up assessment or concern for individual's compliance with the&#xD;
             protocol procedures;&#xD;
&#xD;
          -  Participation in an investigational trial of a drug or device within 30 days prior to&#xD;
             screening&#xD;
&#xD;
          -  BMI &lt; 18 kg/m^2&#xD;
&#xD;
        Note: Other protocol defined Inclusion/Exclusion criteria may apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gilead Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Gilead Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic Hospital</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern California Liver Centers</name>
      <address>
        <city>Coronado</city>
        <state>California</state>
        <zip>92118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California, San Diego (UCSD)</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California San Francisco (UCSF)</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Miami Veterans Administration Healthcare System</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tampa General Hospital</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indianapolis Gastroenterology Research Foundation</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46237</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iowa Digestive Disease Center</name>
      <address>
        <city>Clive</city>
        <state>Iowa</state>
        <zip>50325</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Louisville</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tulane University</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Walter Reed National Military Medical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20889</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lahey Clinic</name>
      <address>
        <city>Burlington</city>
        <state>Massachusetts</state>
        <zip>01805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minnnesota Gastroenterology, PA</name>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <zip>55114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Mississippi Medical Center</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Louis University Hospital</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State University Of New York</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Medical College</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Case Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Gastroenterology</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Clinical Research Institute, LLC</name>
      <address>
        <city>Arlington</city>
        <state>Texas</state>
        <zip>76012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brooke Army Medical Center</name>
      <address>
        <city>Fort Sam Houston</city>
        <state>Texas</state>
        <zip>78234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Luke's Episcopal Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alamo Clinical Research Associates</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Virginia Health System</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Liver Institute of Virginia</name>
      <address>
        <city>Newport News</city>
        <state>Virginia</state>
        <zip>23602</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Digestive and Liver Disease Specialists</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bucheon St. Marys Hospital</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Commonwealth University Health System</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Mason Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Erasme</name>
      <address>
        <city>Brussels</city>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Université Catholique de Louvain</name>
      <address>
        <city>Bruxelles</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Ghent</name>
      <address>
        <city>Gent</city>
        <zip>B-9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Calgary</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 4Z6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Manitoba</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3E 3P4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>London Health Science Center</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5A5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toronto Liver Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M6H 3M1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Beaujon</name>
      <address>
        <city>Clichy</city>
        <zip>92110</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Saint-Antoine</name>
      <address>
        <city>Paris</city>
        <zip>75012</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Groupe Hospitalier Pitié- Salpétrière</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Strasbourg Hôpital Civil</name>
      <address>
        <city>Strasbourg</city>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Hochschule Hannover</name>
      <address>
        <city>Hannover</city>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterologisch-Hepatologisches Zentrum Kiel</name>
      <address>
        <city>Kiel</city>
        <zip>24146</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EUGASTRO GmbH</name>
      <address>
        <city>Leipzig</city>
        <zip>4103</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero-Universitaria di Modena Policlinico</name>
      <address>
        <city>Modena</city>
        <zip>41100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera San Camillo Forlanini</name>
      <address>
        <city>Roma</city>
        <zip>152</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Città della Salute e della Scienza di Torino</name>
      <address>
        <city>Torino</city>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundacion De Investigacion</name>
      <address>
        <city>San Juan</city>
        <zip>00927</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Puerta de Hierro</name>
      <address>
        <city>Majadahonda</city>
        <zip>28222</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Donostia</name>
      <address>
        <city>San Sebastian</city>
        <zip>20080</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John Radcliffe Hospital</name>
      <address>
        <city>Headington</city>
        <zip>OX3 9DU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Royal London Hospital</name>
      <address>
        <city>London</city>
        <zip>E1 1BB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Free Hospital, Pond Street</name>
      <address>
        <city>London</city>
        <zip>NW3 2QG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King's College Hospital NHS Foundation Trust No. 1 Account</name>
      <address>
        <city>London</city>
        <zip>SE5 9RS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nottingham University Hospitals Queens Medica</name>
      <address>
        <city>Nottingham</city>
        <zip>NG7 2UH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Canada</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Puerto Rico</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Sanyal A, Harrison S, Ratziu V, Abdelmalek M, Diehl A, Caldwell S, et al. Changes in fibrosis, but not the NAFLD Activity Score (NAS), are associated with disease progression in patients with nonalcoholic steatohepatitis (NASH) and advanced fibrosis. J Hepatol 2017; 66 (1): S2.</citation>
  </results_reference>
  <results_reference>
    <citation>Sanyal A, Abdelmalek M, Diehl A, Caldwell S, Shiffman M, Ghalib R, et al. Efficacy and safety of simtuzumab for the treatment of nonalcoholic steatohepatitis with bridging fibrosis or cirrhosis: results of two phase 2b, dose-ranging, randomized, placebo-controlled trials. J Hepatol 2017; 66 (1): S54.</citation>
  </results_reference>
  <results_reference>
    <citation>Ratziu V, Sanyal A, Torres D, Hinrichsen H, Serfaty L, Bambha K, et al. Impact of weight reduction on serum markers and liver histology including progression to cirrhosis in patients with nonalcoholic steatohepatitis (NASH) and bridging fibrosis. J Hepatol 2017; 66 (1): S594.</citation>
  </results_reference>
  <results_reference>
    <citation>Shea PR, Sanyal A, Harrison S, Ratziu V, Loomba R, Caldwell S, et al. PNPLA3 variants confer an increased risk of advanced fibrosis due to non-alcoholic steatohepatitis. J Hepatol 2016; 64 (2): S493.</citation>
  </results_reference>
  <results_reference>
    <citation>Shea PR, Sanyal A, Rockey DC, Loomba R, Diehl AM, Kleinstein SE, et al. Genome-wide association study of clinically significant portal hypertension in patients with nonalcoholic steatohepatitis and advanced fibrosis. J Hepatol 2016; 64 (2): S280.</citation>
  </results_reference>
  <results_reference>
    <citation>Goodman ZD, Alaparthi L, Monge F, Patel K, Loomba R, Caldwell SH, et al. Correlations between hepatic morphometric collagen content, histologic fibrosis staging, and serum markers in patients with advanced fibrosis due to nonalcoholic steatohepatitis (NASH). Hepatol 2015; 62 (1): 906A.</citation>
  </results_reference>
  <results_reference>
    <citation>Harrison SA, Goodman ZD, Ratziu V, Loomba R, Diehl AM, Lawitz E, et al. Serum lysyl oxidase-like-2 (sLOXL2) levels correlate with fibrosis stage in patients with nonalcoholic steatohepatitis (NASH). Hepatol 2015; 62 (1): 910A.</citation>
  </results_reference>
  <results_reference>
    <citation>Ratziu V, Sanyal AJ, Loomba R, Caldwell SH, Ghalib RH, Torres DM, et al. Characterization of insulin resistance in patients with advanced fibrosis due to nonalcoholic steatohepatitis (NASH). Hepatol 2015; 62 (1): 1298A-1299A.</citation>
  </results_reference>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>August 22, 2012</study_first_submitted>
  <study_first_submitted_qc>August 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2012</study_first_posted>
  <results_first_submitted>March 1, 2019</results_first_submitted>
  <results_first_submitted_qc>March 1, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">March 27, 2019</results_first_posted>
  <disposition_first_submitted>February 23, 2017</disposition_first_submitted>
  <disposition_first_submitted_qc>February 23, 2017</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">February 24, 2017</disposition_first_posted>
  <last_update_submitted>March 1, 2019</last_update_submitted>
  <last_update_submitted_qc>March 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 27, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>NASH</keyword>
  <keyword>noncirrhotic</keyword>
  <keyword>Monoclonal antibody</keyword>
  <keyword>LOXL2</keyword>
  <keyword>Simtuzumab</keyword>
  <keyword>Nonalcoholic Steatohepatitis</keyword>
  <keyword>NAFLD</keyword>
  <keyword>Liver biopsy</keyword>
  <keyword>MRE</keyword>
  <keyword>Liver fibrosis</keyword>
  <keyword>Ishak</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatty Liver</mesh_term>
    <mesh_term>Liver Cirrhosis</mesh_term>
    <mesh_term>Non-alcoholic Fatty Liver Disease</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were enrolled at study sites in Europe and North America. The first participant was screened on 05 December 2012. The last study visit occurred on 29 December 2016.</recruitment_details>
      <pre_assignment_details>631 participants were screened.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>SIM 75 mg</title>
          <description>Blinded Phase: Participants received simtuzumab (SIM) 75 mg via subcutaneous injection weekly for up to 240 weeks. Open-Label Phase: Participants received SIM 125 mg via subcutaneous injection weekly for up to an additional 240 weeks.</description>
        </group>
        <group group_id="P2">
          <title>SIM 125 mg</title>
          <description>Blinded Phase: Participants received SIM 125 mg via subcutaneous injection weekly for up to 240 weeks. Open-Label Phase: Participants received SIM 125 mg via subcutaneous injection weekly for up to an additional 240 weeks.</description>
        </group>
        <group group_id="P3">
          <title>Placebo</title>
          <description>Blinded Phase: Participants received placebo to match SIM via subcutaneous injection weekly for up to 240 weeks. Open-Label Phase: Participants received SIM 125 mg via subcutaneous injection weekly for up to an additional 240 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Blinded Phase (up to 240 Weeks)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="74"/>
                <participants group_id="P2" count="74"/>
                <participants group_id="P3" count="74"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="74"/>
                <participants group_id="P2" count="74"/>
                <participants group_id="P3" count="74"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Study Terminated by Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
                <participants group_id="P2" count="42"/>
                <participants group_id="P3" count="35"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrew Consent</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="12"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Investigator's Discretion</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Randomized but Never Treated</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Met protocol-specified reason(s)</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="16"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Open-Label Phase (up to 240 Weeks)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="11">Met protocol-specified reason(s) for study discontinuation during Blinded Phase &amp; entered Open-Label</participants>
                <participants group_id="P2" count="15">Met protocol-specified reason(s) for study discontinuation during Blinded Phase &amp; entered Open-Label</participants>
                <participants group_id="P3" count="16">Met protocol-specified reason(s) for study discontinuation during Blinded Phase &amp; entered Open-Label</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="16"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Study Terminated by Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="15"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrew Consent</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>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <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="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety Analysis Set included all enrolled participants who were randomized and received at least one dose of study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>SIM 75 mg</title>
          <description>Blinded Phase: Participants received SIM 75 mg via subcutaneous injection weekly for up to 240 weeks. Open-Label Phase: Participants received SIM 125 mg via subcutaneous injection weekly for up to an additional 240 weeks.</description>
        </group>
        <group group_id="B2">
          <title>SIM 125 mg</title>
          <description>Blinded Phase: Participants received SIM 125 mg via subcutaneous injection weekly for up to 240 weeks. Open-Label Phase: Participants received SIM 125 mg via subcutaneous injection weekly for up to an additional 240 weeks.</description>
        </group>
        <group group_id="B3">
          <title>Placebo</title>
          <description>Blinded Phase: Participants received placebo to match SIM via subcutaneous injection weekly for up to 240 weeks. Open-Label Phase: Participants received SIM 125 mg via subcutaneous injection weekly for up to an additional 240 weeks.</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="71"/>
            <count group_id="B2" value="74"/>
            <count group_id="B3" value="74"/>
            <count group_id="B4" value="219"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54" spread="8.8"/>
                    <measurement group_id="B2" value="53" spread="9.4"/>
                    <measurement group_id="B3" value="53" spread="8.4"/>
                    <measurement group_id="B4" value="53" spread="8.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="48"/>
                    <measurement group_id="B4" value="138"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="26"/>
                    <measurement group_id="B4" value="81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race</title>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="66"/>
                    <measurement group_id="B2" value="71"/>
                    <measurement group_id="B3" value="69"/>
                    <measurement group_id="B4" value="206"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Ethnicity</title>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="63"/>
                    <measurement group_id="B4" value="185"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Belgium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="58"/>
                    <measurement group_id="B3" value="54"/>
                    <measurement group_id="B4" value="163"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Italy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>France</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Morphometric Quantitative Collagen (MQC)</title>
          <units>percentage of liver collagen</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.0" spread="4.18"/>
                    <measurement group_id="B2" value="7.2" spread="4.62"/>
                    <measurement group_id="B3" value="6.7" spread="3.78"/>
                    <measurement group_id="B4" value="7.0" spread="4.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in MQC on Liver Biopsy</title>
        <time_frame>Baseline to Week 96</time_frame>
        <population>Participants in the Full Analysis Set (all enrolled participants who were randomized and received at least 1 dose of study drug) with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>SIM 75 mg</title>
            <description>Blinded Phase: Participants received SIM 75 mg via subcutaneous injection weekly for up to 240 weeks. Open-Label Phase: Participants received SIM 125 mg via subcutaneous injection weekly for up to an additional 240 weeks.</description>
          </group>
          <group group_id="O2">
            <title>SIM 125 mg</title>
            <description>Blinded Phase: Participants received SIM 125 mg via subcutaneous injection weekly for up to 240 weeks. Open-Label Phase: Participants received SIM 125 mg via subcutaneous injection weekly for up to an additional 240 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Blinded Phase: Participants received placebo to match SIM via subcutaneous injection weekly for up to 240 weeks. Open-Label Phase: Participants received SIM 125 mg via subcutaneous injection weekly for up to an additional 240 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in MQC on Liver Biopsy</title>
          <population>Participants in the Full Analysis Set (all enrolled participants who were randomized and received at least 1 dose of study drug) with available data were analyzed.</population>
          <units>percentage of liver collagen</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="49"/>
                <count group_id="O3" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.1" spread="4.83"/>
                    <measurement group_id="O2" value="-2.5" spread="5.11"/>
                    <measurement group_id="O3" value="-1.9" spread="4.28"/>
                  </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>
            <groups_desc>A mixed-effect model for repeated measures (MMRM) with an unstructured variance-covariance matrix for each participant was used to calculate a point estimate and a 95% confidence interval (CI) for the treatment difference between each treatment arm and placebo in least squares mean (LSMean) change from baseline in MQC at Week 96. With MMRM setting, all participants with available data from 3 treatment groups with change in MQC at Week 48 and/or Week 96 contributed to the overall model.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Difference in LSMeans [SIM - Placebo]</param_type>
            <param_value>-0.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.3</ci_lower_limit>
            <ci_upper_limit>1.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>An MMRM with an unstructured variance-covariance matrix for each participant was used to calculate a point estimate and a 95% CI for the treatment difference between each treatment arm and placebo in LSMean change from baseline in MQC at Week 96. With MMRM setting, all participants with available data from 3 treatment groups with change in MQC at Week 48 and/or Week 96 contributed to the overall model.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Difference in LSMeans [SIM - Placebo]</param_type>
            <param_value>-0.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.5</ci_lower_limit>
            <ci_upper_limit>0.8</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Event Free Survival (EFS) Using Kaplan-Meier</title>
        <description>The EFS was the primary clinical efficacy endpoint and was assessed by the time to progression to cirrhosis. Participants were considered to have become cirrhotic if they had a post-baseline biopsy consistent with cirrhosis or developed overt signs and symptoms of cirrhosis. All overt signs and symptoms went through an adjudication process and were confirmed before they were considered for the EFS analysis.</description>
        <time_frame>Baseline up to the time of progression to cirrhosis or last dose date (maximum: 240 weeks in the Blinded Phase), which ever occurred first</time_frame>
        <population>Participants in the Full Analysis Set were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>SIM 75 mg</title>
            <description>Blinded Phase: Participants received SIM 75 mg via subcutaneous injection weekly for up to 240 weeks. Open-Label Phase: Participants received SIM 125 mg via subcutaneous injection weekly for up to an additional 240 weeks.</description>
          </group>
          <group group_id="O2">
            <title>SIM 125 mg</title>
            <description>Blinded Phase: Participants received SIM 125 mg subcutaneous injection weekly for up to 240 weeks. Open-Label Phase: Participants received SIM 125 mg subcutaneous injection weekly for up to an additional 240 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Blinded Phase: Participants received placebo to match SIM via subcutaneous injection weekly for up to 240 weeks. Open-Label Phase: Participants received SIM 125 mg via subcutaneous injection weekly for up to an additional 240 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Event Free Survival (EFS) Using Kaplan-Meier</title>
          <description>The EFS was the primary clinical efficacy endpoint and was assessed by the time to progression to cirrhosis. Participants were considered to have become cirrhotic if they had a post-baseline biopsy consistent with cirrhosis or developed overt signs and symptoms of cirrhosis. All overt signs and symptoms went through an adjudication process and were confirmed before they were considered for the EFS analysis.</description>
          <population>Participants in the Full Analysis Set were analyzed.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Data was not estimable as more than 50% of participants were censored.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Data was not estimable as more than 50% of participants were censored.</measurement>
                    <measurement group_id="O3" value="NA" lower_limit="38.4" upper_limit="NA">Data was not estimable as more than 50% of participants were censored.</measurement>
                  </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>Differences in EFS between a given SIM group and placebo were assessed using the log-rank test stratified by the presence or absence of diabetes at baseline.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.73</p_value>
            <method>Stratified log-rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Differences in EFS between a given SIM group and placebo were assessed using the log-rank test stratified by the presence or absence of diabetes at baseline.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.85</p_value>
            <method>Stratified log-rank test</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline up to the last dose date plus 30 days (average exposure: SIM 75 mg= 112.3 weeks, SIM 125 mg= 111.0 weeks, Placebo= 111.3 weeks, Open-label SIM= 51.0 weeks)</time_frame>
      <desc>Safety Analysis Set included all enrolled participants who were randomized and received at least one dose of study drug and Open-Label Safety Analysis Set included all participants who rolled over into the open-label phase and received at least 1 dose of open-label study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>Blinded Phase: SIM 75 mg</title>
          <description>Adverse events reported in this group occurred during the Blinded Phase. Participants received SIM 75 mg via subcutaneous injection weekly for up to 240 weeks.</description>
        </group>
        <group group_id="E2">
          <title>Blinded Phase: SIM 125 mg</title>
          <description>Adverse events reported in this group occurred during the Blinded Phase. Participants received SIM 125 mg via subcutaneous injection weekly for up to 240 weeks.</description>
        </group>
        <group group_id="E3">
          <title>Blinded Phase: Placebo</title>
          <description>Adverse events reported in this group occurred during the Blinded Phase. Participants received placebo to match SIM via subcutaneous injection weekly for up to 240 weeks.</description>
        </group>
        <group group_id="E4">
          <title>Open-Label Phase: SIM 125 mg</title>
          <description>All participants who completed the Blinded Phase through the Week 240 visit, or were ongoing at the time the study stopped, or who had progressed cirrhosis of the liver, were offered the opportunity to receive open-label SIM for up to 240 additional weeks. Additionally, participants who developed confirmed progression to cirrhosis prior to completing the Blinded Phase were eligible to roll over into the open-label phase. Adverse events reported in this group occurred during the Open-Label Phase. All participants received fixed-dose open-label SIM 125 mg via subcutaneous injection every week for up to 240 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 19.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="11" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Pancytopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Coronary artery occlusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Ventricular tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </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="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperadrenocorticism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </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="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Diverticular perforation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Duodenitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Impaired gastric emptying</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Melaena</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Biliary dilatation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Perforation bile duct</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abscess soft tissue</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Groin abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Infective exacerbation of chronic obstructive airways disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Mastoiditis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="42"/>
              </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" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Seroma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Upper limb fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood glucose increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus inadequate control</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Metabolic acidosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Metabolic disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </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" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Joint instability</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Osteonecrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Adenocarcinoma gastric</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Ovarian adenoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Rectal adenocarcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Carpal tunnel syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Depressed level of consciousness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Epilepsy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Hepatic encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Major depression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Bladder prolapse</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 19.1</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="65" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="69" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="72" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="29" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="17" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Abdominal tenderness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="21" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="22" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="24" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Injection site bruising</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatomegaly</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Localised infection</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Tooth abscess</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood glucose increased</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Vitamin D deficiency</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="18" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="20" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Carpal tunnel syndrome</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Palmar erythema</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="42"/>
              </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>After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:&#xD;
The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or&#xD;
The study has been completed at all study sites for at least 2 years</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Gilead Clinical Study Information Center</name_or_title>
      <organization>Gilead Sciences</organization>
      <phone>1-833-445-3230 (GILEAD-0)</phone>
      <email>GileadClinicalTrials@gilead.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01672866
org study id: GS-US-321-0105
secondary id: 2012-002488-88
nct id: NCT01672866
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The primary objective of this study is to evaluate whether SIM (formerly referred to as
      GS-6624) is effective at preventing the histologic progression of liver fibrosis and the
      clinical progression to cirrhosis in participants with NASH.

      It will consist of 2 phases:

        -  Randomized Double-Blind Phase

        -  Open-Label Phase (optional)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change From Baseline in MQC on Liver Biopsy
time frame: Baseline to Week 96
measure: Event Free Survival (EFS) Using Kaplan-Meier
time frame: Baseline up to the time of progression to cirrhosis or last dose date (maximum: 240 weeks in the Blinded Phase), which ever occurred first
description: The EFS was the primary clinical efficacy endpoint and was assessed by the time to progression to cirrhosis. Participants were considered to have become cirrhotic if they had a post-baseline biopsy consistent with cirrhosis or developed overt signs and symptoms of cirrhosis. All overt signs and symptoms went through an adjudication process and were confirmed before they were considered for the EFS analysis.
arm group label: SIM 75 mg
arm group type: Experimental
description: During the Randomized Double-Blind Phase, participants will receive SIM 75 mg via subcutaneous injection once weekly for up to 240 weeks. During the optional Open-Label Phase, participants will receive SIM 125 mg via subcutaneous injection once weekly for up to an additional 240 weeks.
arm group label: SIM 125 mg
arm group type: Experimental
description: During the Randomized Double-Blind Phase, participants will receive SIM 125 mg via subcutaneous injection once weekly for up to 240 weeks. During the optional Open-Label Phase, participants will receive SIM 125 mg via subcutaneous injection once weekly for up to an additional 240 weeks.
arm group label: Placebo
arm group type: Placebo Comparator
description: During the Randomized Double-Blind Phase, participants will receive placebo to match SIM via subcutaneous injection once weekly for up to 240 weeks. During the optional Open-Label Phase, participants will receive SIM 125 mg via subcutaneous injection once weekly for up to an additional 240 weeks.
intervention type: Biological
intervention name: Placebo
description: Placebo to match SIM via subcutaneous injection every week
arm group label: Placebo
intervention type: Biological
intervention name: SIM
description: Subcutaneous injection every week
arm group label: Placebo
arm group label: SIM 125 mg
arm group label: SIM 75 mg
other name: GS-6624
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Gilead Study Director
role: Study Director
affiliation: Gilead Sciences
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country: Belgium
country: Canada
country: France
country: Germany
country: Italy
country: Puerto Rico
country: Spain
country: United Kingdom
country: United States
citation: Sanyal A, Harrison S, Ratziu V, Abdelmalek M, Diehl A, Caldwell S, et al. Changes in fibrosis, but not the NAFLD Activity Score (NAS), are associated with disease progression in patients with nonalcoholic steatohepatitis (NASH) and advanced fibrosis. J Hepatol 2017; 66 (1): S2.
citation: Sanyal A, Abdelmalek M, Diehl A, Caldwell S, Shiffman M, Ghalib R, et al. Efficacy and safety of simtuzumab for the treatment of nonalcoholic steatohepatitis with bridging fibrosis or cirrhosis: results of two phase 2b, dose-ranging, randomized, placebo-controlled trials. J Hepatol 2017; 66 (1): S54.
citation: Ratziu V, Sanyal A, Torres D, Hinrichsen H, Serfaty L, Bambha K, et al. Impact of weight reduction on serum markers and liver histology including progression to cirrhosis in patients with nonalcoholic steatohepatitis (NASH) and bridging fibrosis. J Hepatol 2017; 66 (1): S594.
citation: Shea PR, Sanyal A, Harrison S, Ratziu V, Loomba R, Caldwell S, et al. PNPLA3 variants confer an increased risk of advanced fibrosis due to non-alcoholic steatohepatitis. J Hepatol 2016; 64 (2): S493.
citation: Shea PR, Sanyal A, Rockey DC, Loomba R, Diehl AM, Kleinstein SE, et al. Genome-wide association study of clinically significant portal hypertension in patients with nonalcoholic steatohepatitis and advanced fibrosis. J Hepatol 2016; 64 (2): S280.
citation: Goodman ZD, Alaparthi L, Monge F, Patel K, Loomba R, Caldwell SH, et al. Correlations between hepatic morphometric collagen content, histologic fibrosis staging, and serum markers in patients with advanced fibrosis due to nonalcoholic steatohepatitis (NASH). Hepatol 2015; 62 (1): 906A.
citation: Harrison SA, Goodman ZD, Ratziu V, Loomba R, Diehl AM, Lawitz E, et al. Serum lysyl oxidase-like-2 (sLOXL2) levels correlate with fibrosis stage in patients with nonalcoholic steatohepatitis (NASH). Hepatol 2015; 62 (1): 910A.
citation: Ratziu V, Sanyal AJ, Loomba R, Caldwell SH, Ghalib RH, Torres DM, et al. Characterization of insulin resistance in patients with advanced fibrosis due to nonalcoholic steatohepatitis (NASH). Hepatol 2015; 62 (1): 1298A-1299A.
responsible party type: Sponsor
mesh term: Fatty Liver
mesh term: Liver Cirrhosis
mesh term: Non-alcoholic Fatty Liver Disease
mesh term: Fibrosis
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 