<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/NCT03028740</url>
  </required_header>
  <id_info>
    <org_study_id>3152-301-002</org_study_id>
    <secondary_id>2016-004566-26</secondary_id>
    <secondary_id>1001</secondary_id>
    <nct_id>NCT03028740</nct_id>
  </id_info>
  <brief_title>AURORA: A Study for the Efficacy and Safety of Cenicriviroc (CVC) for the Treatment of Liver Fibrosis in Adults With Nonalcoholic Steatohepatitis (NASH)</brief_title>
  <acronym>AURORA</acronym>
  <official_title>AURORA: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects With Nonalcoholic Steatohepatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tobira Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tobira Therapeutics, Inc.</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 AURORA study will be conducted to confirm the efficacy and safety of cenicriviroc (CVC)&#xD;
      for the treatment of liver fibrosis in adult participants with NASH.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The AURORA study will be conducted in 2 parts. Part 1 will examine the surrogate endpoint of&#xD;
      improvement in fibrosis of at least 1 stage (nonalcoholic steatohepatitis clinical research&#xD;
      network [NASH CRN]) and no worsening of steatohepatitis at Month 12. Participants from Part 1&#xD;
      will continue into Part 2 and additional participants will be newly randomized in Part 2 to&#xD;
      determine long-term clinical outcomes composed of histopathologic progression to cirrhosis,&#xD;
      liver-related clinical outcomes, and all-cause mortality.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    This study was terminated early due to lack of efficacy based on the results of the planned&#xD;
    interim analysis of Part 1 data.&#xD;
  </why_stopped>
  <start_date type="Actual">April 5, 2017</start_date>
  <completion_date type="Actual">March 9, 2021</completion_date>
  <primary_completion_date type="Actual">January 12, 2021</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Part 1: Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage and No Worsening of Steatohepatitis on Liver Histology at Month 12</measure>
    <time_frame>Month 12</time_frame>
    <description>Fibrosis stage was evaluated using the Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) Fibrosis Staging System with stages: 0=none; 1=perisinusoidal or periportal; 1A=mild, zone 3, perisinusoidal; 1B=moderate, zone 3, perisinusoidal; 1C=portal/periportal; 2=perisinusoidal and portal/periportal; 3=bridging fibrosis; 4=cirrhosis. No worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade as per scoring in relevant nonalcoholic fatty liver disease activity score (NAS) categories. NAS is a semiquantitative scoring system based on the unweighted sum of: steatosis (0=&lt;5% to 3=&gt;66%), lobular inflammation (0=no foci to 3=&gt;4 foci/200x), and hepatocellular ballooning (0=none to 2=many cells/prominent ballooning) scores. Improvement in fibrosis is a decrease in the NASH CRN fibrosis stage.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to First Occurrence of Adjudicated Events in the Full Study Cohort</measure>
    <time_frame>From first dose of study drug to onset of first occurrence of the event (Up to approximately 42 months)</time_frame>
    <description>Time to first occurrence from Baseline was defined as the number of days from the first dose of randomized investigational product to the onset of the first occurrence of any of the following adjudicated events: death (all cause), histopathologic progression to cirrhosis, liver transplant, model for end stage liver disease (MELD) score ≥15, ascites, hospitalization for onset of: variceal bleed, hepatic encephalopathy, spontaneous bacterial peritonitis. MELD is a scoring system for assessing the severity of chronic liver disease and uses the participant's values for total bilirubin, serum creatinine, and the international normalized ratio for prothrombin time to predict survival. MELD score ranges from 6 (less ill) to 40 (gravely ill) with scores and mortality probability being: Score 40=71.3% mortality; Scores 30-39=52.6% mortality; Scores 20-29=19.6% mortality; Scores10-19=6.0% mortality; Score 9 or less=1.9% mortality.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Part 1: Percentage of Participants With Improvement in Fibrosis by at Least 2 Stages and No Worsening of Steatohepatitis on Liver Histology at Month 12</measure>
    <time_frame>Month 12</time_frame>
    <description>Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages: 0=none; 1=perisinusoidal or periportal; 1A=mild, zone 3, perisinusoidal; 1B=moderate, zone 3, perisinusoidal; 1C=portal/periportal; 2=perisinusoidal and portal/periportal; 3=bridging fibrosis; 4=cirrhosis. No worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade as per scoring in relevant NAS categories. NAS is a semiquantitative scoring system based on the unweighted sum of: steatosis (0=&lt;5% to 3=&gt;66%), lobular inflammation (0=no foci to 3=&gt;4 foci/200x), and hepatocellular ballooning (0=none to 2=many cells/prominent ballooning) scores. Improvement in fibrosis is a decrease in the NASH CRN fibrosis stage.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 1: Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage Regardless of Effect on Steatohepatitis at Month 12</measure>
    <time_frame>Month 12</time_frame>
    <description>Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages 0=none, 1=perisinusoidal or periportal, 1A=mild, zone 3, perisinusoidal, 1B=moderate, zone 3, perisinusoidal, 1C=portal/periportal, 2=perisinusoidal and portal/periportal, 3=bridging fibrosis, 4=cirrhosis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 1: Percentage of Participants With Improvement in Fibrosis by at Least 2 Stages Regardless of Effect on Steatohepatitis at Month 12</measure>
    <time_frame>Month 12</time_frame>
    <description>Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages 0=none, 1=perisinusoidal or periportal, 1A=mild, zone 3, perisinusoidal, 1B=moderate, zone 3, perisinusoidal, 1C=portal/periportal, 2=perisinusoidal and portal/periportal, 3=bridging fibrosis, 4=cirrhosis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage and No Worsening of Steatohepatitis on Liver Biopsy at Month 12 in the Full Study Cohort</measure>
    <time_frame>Month 12</time_frame>
    <description>Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages: 0=none; 1=perisinusoidal or periportal; 1A=mild, zone 3, perisinusoidal; 1B=moderate, zone 3, perisinusoidal; 1C=portal/periportal; 2=perisinusoidal and portal/periportal; 3=bridging fibrosis; 4=cirrhosis. No worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade as per scoring in relevant NAS categories. NAS is a semiquantitative scoring system based on the unweighted sum of: steatosis (0=&lt;5% to 3=&gt;66%), lobular inflammation (0=no foci to 3=&gt;4 foci/200x), and hepatocellular ballooning (0=none to 2=many cells/prominent ballooning) scores. Improvement in fibrosis is a decrease in the NASH CRN fibrosis stage.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage Regardless of Effect on Steatohepatitis on Liver Biopsy at Month 12 in the Full Study Cohort</measure>
    <time_frame>Month 12</time_frame>
    <description>Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages 0=none, 1=perisinusoidal or periportal, 1A=mild, zone 3, perisinusoidal, 1B=moderate, zone 3, perisinusoidal, 1C=portal/periportal, 2=perisinusoidal and portal/periportal, 3=bridging fibrosis, 4=cirrhosis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Improvement in Fibrosis by at Least 2 Stages and No Worsening of Steatohepatitis on Liver Biopsy at Month 12 in the Full Study Cohort</measure>
    <time_frame>Month 12</time_frame>
    <description>Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages: 0=none; 1=perisinusoidal or periportal; 1A=mild, zone 3, perisinusoidal; 1B=moderate, zone 3, perisinusoidal; 1C=portal/periportal; 2=perisinusoidal and portal/periportal; 3=bridging fibrosis; 4=cirrhosis. No worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade as per scoring in relevant NAS categories. NAS is a semiquantitative scoring system based on the unweighted sum of: steatosis (0=&lt;5% to 3=&gt;66%), lobular inflammation (0=no foci to 3=&gt;4 foci/200x), and hepatocellular ballooning (0=none to 2=many cells/prominent ballooning) scores. Improvement in fibrosis is a decrease in the NASH CRN fibrosis stage.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Improvement in Fibrosis by at Least 2 Stages Regardless of Effect on Steatohepatitis on Liver Biopsy at Month 12 in the Full Study Cohort</measure>
    <time_frame>Month 12</time_frame>
    <description>Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages 0=none, 1=perisinusoidal or periportal, 1A=mild, zone 3, perisinusoidal, 1B=moderate, zone 3, perisinusoidal, 1C=portal/periportal, 2=perisinusoidal and portal/periportal, 3=bridging fibrosis, 4=cirrhosis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage and No Worsening of Steatohepatitis on Liver Biopsy at Month 60 in the Full Study Cohort</measure>
    <time_frame>Month 60</time_frame>
    <description>Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages: 0=none; 1=perisinusoidal or periportal; 1A=mild, zone 3, perisinusoidal; 1B=moderate, zone 3, perisinusoidal; 1C=portal/periportal; 2=perisinusoidal and portal/periportal; 3=bridging fibrosis; 4=cirrhosis. No worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade as per scoring in relevant NAS categories. NAS is a semiquantitative scoring system based on the unweighted sum of: steatosis (0=&lt;5% to 3=&gt;66%), lobular inflammation (0=no foci to 3=&gt;4 foci/200x), and hepatocellular ballooning (0=none to 2=many cells/prominent ballooning) scores. Improvement in fibrosis is a decrease in the NASH CRN fibrosis stage.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage Regardless of Effect on Steatohepatitis on Liver Biopsy at Month 60 in the Full Study Cohort</measure>
    <time_frame>Month 60</time_frame>
    <description>Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages 0=none, 1=perisinusoidal or periportal, 1A=mild, zone 3, perisinusoidal, 1B=moderate, zone 3, perisinusoidal, 1C=portal/periportal, 2=perisinusoidal and portal/periportal, 3=bridging fibrosis, 4=cirrhosis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Improvement in Fibrosis by at Least 2 Stages and No Worsening of Steatohepatitis on Liver Biopsy at Month 60 in the Full Study Cohort</measure>
    <time_frame>Month 60</time_frame>
    <description>Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages: 0=none; 1=perisinusoidal or periportal; 1A=mild, zone 3, perisinusoidal; 1B=moderate, zone 3, perisinusoidal; 1C=portal/periportal; 2=perisinusoidal and portal/periportal; 3=bridging fibrosis; 4=cirrhosis. No worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade as per scoring in relevant NAS categories. NAS is a semiquantitative scoring system based on the unweighted sum of: steatosis (0=&lt;5% to 3=&gt;66%), lobular inflammation (0=no foci to 3=&gt;4 foci/200x), and hepatocellular ballooning (0=none to 2=many cells/prominent ballooning) scores. Improvement in fibrosis is a decrease in the NASH CRN fibrosis stage.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Improvement in Fibrosis by at Least 2 Stages Regardless of Effect on Steatohepatitis on Liver Biopsy at Month 60 in the Full Study Cohort</measure>
    <time_frame>Month 60</time_frame>
    <description>Fibrosis stage was evaluated using NASH CRN Fibrosis Staging System with stages 0=None, 1=Perisinusoidal or periportal, 1A=Mild, zone 3, perisinusoidal, 1B=Moderate, zone 3, perisinusoidal, 1C=Portal/periportal, 2=Perisinusoidal and portal/periportal, 3=Bridging fibrosis, 4=Cirrhosis.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1778</enrollment>
  <condition>Nonalcoholic Steatohepatitis</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants received cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cenicriviroc 150 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received cenicriviroc, 150 milligrams (mg), tablet, orally, once daily for up to approximately 40 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cenicriviroc</intervention_name>
    <description>Cenicriviroc, 150 mg, tablet, orally, once daily for up to approximately 40 months.</description>
    <arm_group_label>Cenicriviroc 150 mg</arm_group_label>
    <other_name>CVC</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female participants aged between 18-75 years&#xD;
&#xD;
          -  Ability to understand and sign a written informed consent form (ICF)&#xD;
&#xD;
          -  Histological evidence of NASH based on central reading of the Screening biopsy&#xD;
&#xD;
          -  Participants included in Part 1 must have histopathological evidence of Stage 2 or 3&#xD;
             liver fibrosis per the NASH CRN System based on central reading of the Screening&#xD;
             biopsy slides. Participants newly randomized in Part 2 must have histological evidence&#xD;
             of Stage 3 liver fibrosis per the NASH CRN System, based on central reading of the&#xD;
             Screening period biopsy slides. Historical biopsy can be used, provided the criteria&#xD;
             listed on Item 3a above are fulfilled.&#xD;
&#xD;
          -  Females of childbearing potential and males participating in the study must agree to&#xD;
             use at least 2 approved methods of contraception throughout the duration of the study&#xD;
             and for 30 days after stopping study drug. Females who are postmenopausal must have&#xD;
             documentation of cessation of menses for ≥12 months and serum follicle-stimulating&#xD;
             hormone (FSH) ≥30 milliunits (mU)/milliliter (mL) at Screening.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to undergo a liver biopsy&#xD;
&#xD;
          -  Hepatitis B surface antigen (HBsAg) positive&#xD;
&#xD;
          -  Hepatitis C antibody (HCVAb) positive&#xD;
&#xD;
          -  Human immunodeficiency virus (HIV)-1 or HIV-2 infection&#xD;
&#xD;
          -  Prior or planned liver transplantation&#xD;
&#xD;
          -  Other known causes of chronic liver disease&#xD;
&#xD;
          -  History or presence of cirrhosis and/or hepatic decompensation including ascites,&#xD;
             hepatic encephalopathy or variceal bleeding&#xD;
&#xD;
          -  Alcohol consumption greater than 21 units/week for males or 14 units/week for females&#xD;
&#xD;
          -  Aspartate transaminase (AST) &gt;200 International units (IU)/liter (L) in males and&#xD;
             females at Screening&#xD;
&#xD;
          -  Alanine transaminase (ALT) &gt;250 IU/L in males and &gt;200 IU/L in females at Screening&#xD;
&#xD;
          -  Hemoglobin A1c (HbA1c) &gt;10% at Screening&#xD;
&#xD;
          -  Serum albumin &lt;3.5 gram (g)/deciliter (dL) at Screening&#xD;
&#xD;
          -  Estimated glomerular filtration rate (eGFR) &lt; 50 mL/minute (min)/1.73 meter (m)^2&#xD;
             according to the Modification of Diet in Renal Disease (MDRD) equation&#xD;
&#xD;
          -  Platelet count &lt;100,000/millimeter (mm)^3&#xD;
&#xD;
          -  Total bilirubin &gt;1.5 milligram (mg)/dL&#xD;
&#xD;
          -  International normalized ratio (INR) &gt;1.3&#xD;
&#xD;
          -  Model of end stage liver disease (MELD) score &gt;12&#xD;
&#xD;
          -  Weight reduction, defined as ≥7% of body weight, through bariatric surgery in the past&#xD;
             5 years or bariatric surgery planned during the conduct of the study (including&#xD;
             gastric banding and sleeve surgery)&#xD;
&#xD;
          -  History of malignancy within the past 5 years or ongoing malignancy other than basal&#xD;
             cell carcinoma, or resected noninvasive cutaneous squamous cell carcinoma&#xD;
&#xD;
          -  Active, serious infections that require parenteral antibiotic or antifungal therapy&#xD;
             within 30 days prior to Screening Visit&#xD;
&#xD;
          -  Clinically significant cardiovascular or cerebrovascular disease within the past 3&#xD;
             months&#xD;
&#xD;
          -  Females who are pregnant or breastfeeding&#xD;
&#xD;
          -  Current or anticipated treatment with radiation therapy, cytotoxic chemotherapeutic&#xD;
             agents and immunomodulating agents (eg, interleukins, interferons, cyclosporine,&#xD;
             tacrolimus) except for vaccines or short-term corticosteroids&#xD;
&#xD;
          -  Receiving a glucagon-like peptide 1 (GLP-1) receptor agonist, a dipeptidyl peptidase 4&#xD;
             (DPP-4) inhibitor, a sodium-glucose cotransporter 2 (SGLT2) and/or sodium-glucose&#xD;
             cotransporter (SGLT1) inhibitor, or a thiazolidinedione (TZD) for less than 6 months&#xD;
             prior to the Screening period liver biopsy. Participants on a stable therapy with a&#xD;
             GLP-1 receptor agonist, DPP-4 inhibitor, SGLT1 and/or SGLT2 inhibitor, or a TZD for at&#xD;
             least 6 months prior to the Screening liver biopsy may be considered eligible.&#xD;
             (Important Note: if a historical biopsy is to be used, participants need to be on&#xD;
             stable therapy for at least 6 months prior to the day historical liver biopsy was&#xD;
             performed).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gerardo Rodriguez</last_name>
    <role>Study Director</role>
    <affiliation>Allergan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Summit Internal Medicine</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35243</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cullman Clinical Trials</name>
      <address>
        <city>Cullman</city>
        <state>Alabama</state>
        <zip>35055</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Digestive Health Specialists of the Southeast</name>
      <address>
        <city>Dothan</city>
        <state>Alabama</state>
        <zip>36305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Objective GI D/B/A North Alabama GI Research Center</name>
      <address>
        <city>Madison</city>
        <state>Alabama</state>
        <zip>35758</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Institute for Liver Health</name>
      <address>
        <city>Chandler</city>
        <state>Arizona</state>
        <zip>85224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adobe Gastroenterology Research, LLC</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Del Sol Research Management, LLC</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Del Sol Research Management LLC</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85745</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arkansas Diagnostic Center</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Franco Felizarta MD</name>
      <address>
        <city>Bakersfield</city>
        <state>California</state>
        <zip>93301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hope Clinical Research</name>
      <address>
        <city>Canoga Park</city>
        <state>California</state>
        <zip>91303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GW Research</name>
      <address>
        <city>Chula Vista</city>
        <state>California</state>
        <zip>91910</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>eStudySite</name>
      <address>
        <city>Chula Vista</city>
        <state>California</state>
        <zip>91911</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern California Research Center</name>
      <address>
        <city>Coronado</city>
        <state>California</state>
        <zip>92118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Citrus Valley Gastroenterology</name>
      <address>
        <city>Covina</city>
        <state>California</state>
        <zip>91722</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TriWest Research Associates</name>
      <address>
        <city>El Cajon</city>
        <state>California</state>
        <zip>92020</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of San Francisco, Fresno Medical Education Program</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fresno Clinical Research Center (FCRC)</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Research Institute</name>
      <address>
        <city>Huntington Park</city>
        <state>California</state>
        <zip>90255</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California San Diego</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>eStudySite</name>
      <address>
        <city>La Mesa</city>
        <state>California</state>
        <zip>91942</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Om Research</name>
      <address>
        <city>Lancaster</city>
        <state>California</state>
        <zip>93534</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern California Kaiser Permanente, Los Angeles Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GastroIntestinal Biosciences</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90036</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Global Research Institute</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90036</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ruane Medical and Liver Health Institute</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90036</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cedars-Sinai Medical Group</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Research Institute</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>United Medical Doctors</name>
      <address>
        <city>Murrieta</city>
        <state>California</state>
        <zip>92563</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Palmtree Clinical Research Inc.</name>
      <address>
        <city>Palm Springs</city>
        <state>California</state>
        <zip>92262</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Research Institute</name>
      <address>
        <city>Panorama City</city>
        <state>California</state>
        <zip>91402</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pasadena Liver Center</name>
      <address>
        <city>Pasadena</city>
        <state>California</state>
        <zip>91105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alliance Clinical Research LLC</name>
      <address>
        <city>Poway</city>
        <state>California</state>
        <zip>92064</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford School of Medicine, Center for Clinical Sciences Research</name>
      <address>
        <city>Redwood City</city>
        <state>California</state>
        <zip>94063</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inland Empire Liver Foundation</name>
      <address>
        <city>Rialto</city>
        <state>California</state>
        <zip>92377-4697</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Precision Research Institute</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern California Permanente Medical Group</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92154</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCSF School of Medicine</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143-0538</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Upland Clinical Research</name>
      <address>
        <city>Upland</city>
        <state>California</state>
        <zip>91786</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Island View GI</name>
      <address>
        <city>Ventura</city>
        <state>California</state>
        <zip>93003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peak Gastroenterology Associates</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80907</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Denver Gastroenterology, PC</name>
      <address>
        <city>Englewood</city>
        <state>Colorado</state>
        <zip>80113</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Western States Clinical Research, Inc.</name>
      <address>
        <city>Wheat Ridge</city>
        <state>Colorado</state>
        <zip>80033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology Associates of Fairfield County</name>
      <address>
        <city>Bridgeport</city>
        <state>Connecticut</state>
        <zip>06606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale University - New Haven</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Innovative Medical Research of South Florida, Inc.</name>
      <address>
        <city>Aventura</city>
        <state>Florida</state>
        <zip>33180</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastro Florida</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33761</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hi Tech and Global Research, LLC</name>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Top Medical Research, Inc</name>
      <address>
        <city>Cutler Bay</city>
        <state>Florida</state>
        <zip>33189</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ICR Sites</name>
      <address>
        <city>Doral</city>
        <state>Florida</state>
        <zip>33166</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Qway Research, LLC</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology Associates - Crystal River</name>
      <address>
        <city>Inverness</city>
        <state>Florida</state>
        <zip>34452</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic College of Medicine</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridien Research</name>
      <address>
        <city>Lakeland</city>
        <state>Florida</state>
        <zip>33803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Digestive Health Specialists</name>
      <address>
        <city>Lakewood Ranch</city>
        <state>Florida</state>
        <zip>34211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridien Research</name>
      <address>
        <city>Maitland</city>
        <state>Florida</state>
        <zip>32751</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Marcus Research Clinic</name>
      <address>
        <city>Miami Lakes</city>
        <state>Florida</state>
        <zip>33014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Pharmacology of Miami, LLC</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bruce W. Carter Department of Veterans Affairs Medical Center</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33125</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Optimus U Corporation</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33125</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami Hospital</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanchez Clinical Research, Inc</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Genoma Research Group Inc.</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33165</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Professional Clinical Research Center, INC</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33165</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ProLive Medical Research</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33175</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Research Institute, Inc.</name>
      <address>
        <city>New Port Richey</city>
        <state>Florida</state>
        <zip>34653</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bioclinical Research Alliance</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Omega Research Maitland, LLC</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32810</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IMIC, Inc</name>
      <address>
        <city>Palmetto Bay</city>
        <state>Florida</state>
        <zip>33157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Innovation Medical Research Center</name>
      <address>
        <city>Palmetto Bay</city>
        <state>Florida</state>
        <zip>33157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology Associates of Pensacola</name>
      <address>
        <city>Pensacola</city>
        <state>Florida</state>
        <zip>32503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Medical Research</name>
      <address>
        <city>Port Orange</city>
        <state>Florida</state>
        <zip>32127</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>Guardian Angel Research Center</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33614</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bioclinica Research</name>
      <address>
        <city>The Villages</city>
        <state>Florida</state>
        <zip>32162</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Medical Clinic</name>
      <address>
        <city>Zephyrhills</city>
        <state>Florida</state>
        <zip>33542</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Summit Clinical Research, LLC</name>
      <address>
        <city>Athens</city>
        <state>Georgia</state>
        <zip>30607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Digestive Healthcare of Georgia - Atlanta</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Piedmont Healthcare INC.</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology Associates of Central Georgia</name>
      <address>
        <city>Macon</city>
        <state>Georgia</state>
        <zip>31201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GI Specialists of Georgia - Marietta Office</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</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>Rush University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigators Research Group, LLC</name>
      <address>
        <city>Brownsburg</city>
        <state>Indiana</state>
        <zip>46112</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>Aquiant Research</name>
      <address>
        <city>New Albany</city>
        <state>Indiana</state>
        <zip>47150</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Digestive Research Alliance of Michiana</name>
      <address>
        <city>South Bend</city>
        <state>Indiana</state>
        <zip>46635</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 Iowa Hospitals and Clinics</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kansas Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kansas Medical Clinic-Gastroenterology</name>
      <address>
        <city>Topeka</city>
        <state>Kansas</state>
        <zip>66606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Delta Research Partners, LLC</name>
      <address>
        <city>Bastrop</city>
        <state>Louisiana</state>
        <zip>71220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Avant Research Associates LLC</name>
      <address>
        <city>Crowley</city>
        <state>Louisiana</state>
        <zip>70526</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>C-1 Headlands, Inc.</name>
      <address>
        <city>Lake Charles</city>
        <state>Louisiana</state>
        <zip>70601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tandem Clinical Research</name>
      <address>
        <city>Marrero</city>
        <state>Louisiana</state>
        <zip>70072</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tulane University School of Medicine</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ochsner Medical Center</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nola Research Works, LLC</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70125</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Louisiana Research Center</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials of America LLC</name>
      <address>
        <city>West Monroe</city>
        <state>Louisiana</state>
        <zip>71291</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>Digestive Disease Associates</name>
      <address>
        <city>Catonsville</city>
        <state>Maryland</state>
        <zip>21228</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastro Center of Maryland</name>
      <address>
        <city>Columbia</city>
        <state>Maryland</state>
        <zip>21045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Woodholme Gastroenterology Associates</name>
      <address>
        <city>Glen Burnie</city>
        <state>Maryland</state>
        <zip>21061</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Victory Clinical Research</name>
      <address>
        <city>Greenbelt</city>
        <state>Maryland</state>
        <zip>20770</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meritus Center for Clinical Research</name>
      <address>
        <city>Hagerstown</city>
        <state>Maryland</state>
        <zip>21742</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</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 Hospital &amp; Medical Center</name>
      <address>
        <city>Burlington</city>
        <state>Massachusetts</state>
        <zip>01805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Umass Memorial Medical Center</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01655</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Health System</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minnesota Gastroenterology, P.A.</name>
      <address>
        <city>Maplewood</city>
        <state>Minnesota</state>
        <zip>55117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Diabetes and Obesity Research Institute</name>
      <address>
        <city>Biloxi</city>
        <state>Mississippi</state>
        <zip>39532</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GastroIntestinal Associates</name>
      <address>
        <city>Flowood</city>
        <state>Mississippi</state>
        <zip>39232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Professionals</name>
      <address>
        <city>Chesterfield</city>
        <state>Missouri</state>
        <zip>63005</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Louis University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Machuca Family Medicine</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jubilee Clinical Research, Inc.</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sierra Clinical Research</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Excel Clinical Research</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dartmouth Hitchcock Medical Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hassman Research Institute</name>
      <address>
        <city>Berlin</city>
        <state>New Jersey</state>
        <zip>08009</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Amici Clinical Research</name>
      <address>
        <city>Raritan</city>
        <state>New Jersey</state>
        <zip>08869</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beth Israel Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NYU Langone Health - Perlmutter Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tandem Clinical Research</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10033</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>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Drug Service, The University of North Carolina at Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27514</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolinas Medical Center</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northeast GI Research Division</name>
      <address>
        <city>Concord</city>
        <state>North Carolina</state>
        <zip>28027</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>Cumberland Research Associates, LLC</name>
      <address>
        <city>Fayetteville</city>
        <state>North Carolina</state>
        <zip>28304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolina Research</name>
      <address>
        <city>Greenville</city>
        <state>North Carolina</state>
        <zip>27834</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Research Associates</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Winston-Salem</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Consultants for Clinical Research</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45249</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MetroHealth Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ohio University - Gastroenterology, Hepatology</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Digestive Disease Specialist, Inc.</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Options Health Research</name>
      <address>
        <city>Tulsa</city>
        <state>Oklahoma</state>
        <zip>74104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eastern Pennsylvania Gastroenterology and Liver Specialist</name>
      <address>
        <city>Bethlehem</city>
        <state>Pennsylvania</state>
        <zip>18017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UPMC -Center for Liver Diseases</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Pittsburgh Healthcare System</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15240</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Care Access Research, Pottsville</name>
      <address>
        <city>Pottsville</city>
        <state>Pennsylvania</state>
        <zip>17901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Digestive Disease Associates, LTD</name>
      <address>
        <city>Wyomissing</city>
        <state>Pennsylvania</state>
        <zip>19610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Partners in Clinical Research</name>
      <address>
        <city>Cumberland</city>
        <state>Rhode Island</state>
        <zip>02864</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Medical Group</name>
      <address>
        <city>North Providence</city>
        <state>Rhode Island</state>
        <zip>02908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Care Access Research-Warwick</name>
      <address>
        <city>Warwick</city>
        <state>Rhode Island</state>
        <zip>02886</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rapid City Medical Center</name>
      <address>
        <city>Rapid City</city>
        <state>South Dakota</state>
        <zip>57701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Vernon Clinical Research</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37421</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastro One</name>
      <address>
        <city>Germantown</city>
        <state>Tennessee</state>
        <zip>38138</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Digestive Health Research</name>
      <address>
        <city>Hermitage</city>
        <state>Tennessee</state>
        <zip>37076</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East Tennessee Research Institute</name>
      <address>
        <city>Johnson City</city>
        <state>Tennessee</state>
        <zip>37604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Digestive Health Research</name>
      <address>
        <city>Lebanon</city>
        <state>Tennessee</state>
        <zip>37090</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UT-Memphis, Methodist University Hospital</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232-1610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Clinical Research Institute</name>
      <address>
        <city>Arlington</city>
        <state>Texas</state>
        <zip>76012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Methodist Dallas Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Liver Center of Texas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Antonio Military 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>Baylor Scott &amp; White All Saints Medical Center - Ft. Worth</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Digestive Disease Consultants - Fort Worth</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Digestive Health Associates of Texas-Rockwall</name>
      <address>
        <city>Garland</city>
        <state>Texas</state>
        <zip>75044</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Therapeutic Concepts, PA</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pioneer Research Solutions, Inc.</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77009</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Liver Associates of Texas</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030-3002</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor College of Medicine</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michael E. DeBakey VA Medical Center (MEDVAMC)</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Luke's Medical Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Biopharma Informatic, LLC</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77043</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centex Studies</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77058</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Biopharma Informatic, LLC</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77084</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Amir Ali Hassan, MD, PA</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77089</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centex Studies, Inc.</name>
      <address>
        <city>McAllen</city>
        <state>Texas</state>
        <zip>78504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LinQ Research, LLC</name>
      <address>
        <city>Pearland</city>
        <state>Texas</state>
        <zip>77584</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Quality Research Inc.</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>American Research Corporation</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials of Texas Inc</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diabetes &amp; Glandular Disease Clinic, P.A. (DGD)</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endeavor Clinical Trials, LLC</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern Star Research Institute, LLC SAGACT PLLC.</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Anson Medicine</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Olympus Medical Research, LLC</name>
      <address>
        <city>Sugar Land</city>
        <state>Texas</state>
        <zip>77479</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Digestive Disease Consultants</name>
      <address>
        <city>Webster</city>
        <state>Texas</state>
        <zip>77598</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Physician's Research Options, LLC</name>
      <address>
        <city>Draper</city>
        <state>Utah</state>
        <zip>84020</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Intermountain Medical Center</name>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Clinical Research - Center for Digestive Health</name>
      <address>
        <city>Riverton</city>
        <state>Utah</state>
        <zip>84065</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>Gastroenterology Associates of Northern Virginia</name>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>22031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inova Fairfax Medical Campus</name>
      <address>
        <city>Falls Church</city>
        <state>Virginia</state>
        <zip>22042</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>McGuire Veterans Affairs Medical Center</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23249</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VCU Medical Center</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology Consultants of Southwest Virginia Research</name>
      <address>
        <city>Roanoke</city>
        <state>Virginia</state>
        <zip>24014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harborview Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Liver Institute Northwest</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marshall University Joan C. Edwards School of Medicine</name>
      <address>
        <city>Huntington</city>
        <state>West Virginia</state>
        <zip>25701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Prince Alfred Hospital</name>
      <address>
        <city>Camperdown</city>
        <state>New South Wales</state>
        <zip>2050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint George Hospital</name>
      <address>
        <city>Kogarah</city>
        <state>New South Wales</state>
        <zip>2217</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Brisbane and Women's Hospital</name>
      <address>
        <city>Herston</city>
        <state>Queensland</state>
        <zip>4029</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Adelaide Hospital</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Flinders Medical Center</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5042</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Monash Medical Centre</name>
      <address>
        <city>Clayton</city>
        <state>Victoria</state>
        <zip>3168</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Austin Health</name>
      <address>
        <city>Heidelberg</city>
        <state>Victoria</state>
        <zip>3084</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Perth Hospital</name>
      <address>
        <city>Perth</city>
        <state>Western Australia</state>
        <zip>6000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinik far Innere Medizin</name>
      <address>
        <city>Graz</city>
        <state>Styria</state>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinik far Innere Medizin II</name>
      <address>
        <city>Innsbruck</city>
        <state>Tyrol</state>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Wels-Grieskirchen</name>
      <address>
        <city>Wels</city>
        <state>Upper Austria</state>
        <zip>4600</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Antwerpen</name>
      <address>
        <city>Edegem</city>
        <state>Antwerpen</state>
        <zip>2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Erasme</name>
      <address>
        <city>Bruxelles</city>
        <state>Brussels</state>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Algemeen Ziekenhuis Maria Middelares</name>
      <address>
        <city>Gent</city>
        <state>Oost-Vlaanderen</state>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Gent</name>
      <address>
        <city>Gent</city>
        <state>Oost-Vlaanderen</state>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cliniques Universitaires Saint-Luc</name>
      <address>
        <city>Brussels</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Chretien CHC</name>
      <address>
        <city>Liege</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital das Clínicas da Universidade Federal de Minas Gerais</name>
      <address>
        <city>Belo Horizonte</city>
        <state>Minas Gerais</state>
        <zip>30130-100</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Faculdade de Medicina de São José do Rio Preto Hospital de Base</name>
      <address>
        <city>São José do Rio Preto</city>
        <state>Sao Paulo</state>
        <zip>15090-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitário Clementino Fraga Filho</name>
      <address>
        <city>Rio de Janeiro</city>
        <zip>21941-913</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo</name>
      <address>
        <city>Sao Paulo</city>
        <zip>05403-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Calgary Liver Unit</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 4Z6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bailey Health Clinic</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T5H 4B9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vancouver General Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 1M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>William Osler Health Centre, Brampton Memorial Hospital Campus</name>
      <address>
        <city>Brampton</city>
        <state>Ontario</state>
        <zip>L6R 3J7</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>Ecogene-21</name>
      <address>
        <city>Chicoutimi</city>
        <state>Quebec</state>
        <zip>G7H 7K9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Investigaciones Clínicas Viña del Mar</name>
      <address>
        <city>Viña del Mar</city>
        <state>Valparaiso</state>
        <zip>2540488</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Strasbourg</name>
      <address>
        <city>Strasbourg cedex</city>
        <state>Alsace</state>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU De Bordeaux - Hôpital Haût-Lévèque CMC Magellan Unita de Recherche Clinique</name>
      <address>
        <city>Pessac</city>
        <state>Aquitaine</state>
        <zip>33604</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Estaing</name>
      <address>
        <city>Clermont-Ferrand</city>
        <state>Aubergne</state>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Rennes- Hôpital Pontchaillou</name>
      <address>
        <city>Rennes</city>
        <state>Bretagne</state>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Regional et Universitaire de Besancon - L'Hopital Jean Minjoz</name>
      <address>
        <city>Besançon cedex</city>
        <state>Franche-Comte</state>
        <zip>25030</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Departement d'Hacpatologie</name>
      <address>
        <city>Clichy</city>
        <state>Ile-De-France</state>
        <zip>92110</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint Antoine</name>
      <address>
        <city>Paris Cedex 12</city>
        <state>Ile-de-France</state>
        <zip>75571</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Montpellier</name>
      <address>
        <city>Montpellier cedex 5</city>
        <state>Languedoc-Roussillon</state>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Rouen CHU de Rouen Hopital Charles-Nicolle</name>
      <address>
        <city>Rouen</city>
        <state>Normandie</state>
        <zip>76000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center Hospitalier Universitaire d'Angers</name>
      <address>
        <city>Angers</city>
        <state>Pays De La Loire</state>
        <zip>49000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hapital Sud Service d'Hepato- Gastroentarologie</name>
      <address>
        <city>Amiens Cedex 1</city>
        <state>Picardie</state>
        <zip>80054</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Nice Hôpital l'Archet</name>
      <address>
        <city>Nice Cedex 3</city>
        <state>Provence Alpes Cote D'Azur</state>
        <zip>06202</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Grenoble</name>
      <address>
        <city>Grenoble Cedex 09</city>
        <state>Rhone-Alpes</state>
        <zip>38700</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Avicenne</name>
      <address>
        <city>Bobigny</city>
        <zip>93000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research GmbH, Prüfzentrum Frankfurt</name>
      <address>
        <city>Frankfurt</city>
        <state>Hessen</state>
        <zip>60313</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Philipps-Universität und Universitätsklinikum Gießen und Marburg GmbH</name>
      <address>
        <city>Marburg</city>
        <state>Hessen</state>
        <zip>35043</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Hochschule Hannover</name>
      <address>
        <city>Hannover</city>
        <state>Niedersachsen</state>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterologische Gemeinschaftspraxis</name>
      <address>
        <city>Herne</city>
        <state>Nordhein-Westfalen</state>
        <zip>44623</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniklinik RWTH Aachen</name>
      <address>
        <city>Aachen</city>
        <state>Nordrhein-Westfalen</state>
        <zip>52074</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniklinik Köln</name>
      <address>
        <city>Köln</city>
        <state>Nordrhein-westfalen</state>
        <zip>50937</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsmedizin der Johannes Gutenberg Universität Mainz</name>
      <address>
        <city>Mainz</city>
        <state>Rheinland-Pfalz</state>
        <zip>55131</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum des Saarlandes</name>
      <address>
        <city>Homburg</city>
        <state>Saarland</state>
        <zip>66427</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Leipzig</name>
      <address>
        <city>Leipzig</city>
        <state>Sachsen</state>
        <zip>04103</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis Driesener Strasse</name>
      <address>
        <city>Berlin</city>
        <zip>10439</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research GmbH, Prüfzentrum Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>12627</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charité Universitätsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Hamburg Eppendorf</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thomopoulos Gastroenterology Dept.</name>
      <address>
        <city>Patra</city>
        <state>Peloponnese</state>
        <zip>26504</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hippokratio Hospital</name>
      <address>
        <city>Thessaloniki</city>
        <zip>54642</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prince of Wales Hospital</name>
      <address>
        <city>Shatin</city>
        <state>New Territories</state>
        <zip>00852</zip>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alice Ho Miu Ling Nethersole Hospital</name>
      <address>
        <city>Shatin</city>
        <state>New Territories</state>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Somogy Megyei Kaposi Mór Oktató Kórház</name>
      <address>
        <city>Kaposvár</city>
        <state>Somogy</state>
        <zip>7400-7400</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SYNEXUS Magyarország Kft. - Budapest DRS</name>
      <address>
        <city>Budapest</city>
        <zip>1036</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft</name>
      <address>
        <city>Debrecen</city>
        <zip>4025</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EMMS MC</name>
      <address>
        <city>Nazareth</city>
        <state>Jerusalem</state>
        <zip>91031</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rambam Health Care Campus - Rambam Medical Center</name>
      <address>
        <city>Haifa</city>
        <zip>31999</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carmel Medical Center</name>
      <address>
        <city>Haifa</city>
        <zip>34362</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shaare Zedek Medical Center</name>
      <address>
        <city>Jerusalem</city>
        <zip>91031</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hadassah Medical Center, Institute of Gastroenterology and Liver Diseases</name>
      <address>
        <city>Jerusalem</city>
        <zip>91120</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galilee Medical Center</name>
      <address>
        <city>Nahariya</city>
        <zip>22100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rabin Medical Center Beilinson Hospital</name>
      <address>
        <city>Petah Tikva</city>
        <zip>49100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tel Aviv Sourasky Medical Center</name>
      <address>
        <city>Tel Aviv</city>
        <zip>64239</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sheba Medical Center</name>
      <address>
        <city>Tel-Hashomer</city>
        <zip>52621</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Casa Sollievo della Sofferenza</name>
      <address>
        <city>San Giovanni Rotondo</city>
        <state>Foggia</state>
        <zip>71013</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASST Grande Ospedale Metropolitano Niguarda</name>
      <address>
        <city>Milan</city>
        <state>Milano</state>
        <zip>20162</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Clinico Humanitas</name>
      <address>
        <city>Rozzano</city>
        <state>Milano</state>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria Careggi SOD Medicina Interna ed Epatologia</name>
      <address>
        <city>Firenze</city>
        <zip>50134</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASST Santi Paolo e Carlo</name>
      <address>
        <city>Milano</city>
        <zip>20142</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone</name>
      <address>
        <city>Palermo</city>
        <zip>90127</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Policlinico Tor Vergata</name>
      <address>
        <city>Roma</city>
        <zip>00133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Policlinico Universitario Agostino Gemelli</name>
      <address>
        <city>Roma</city>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pauls Stradins Clinical University Hospital</name>
      <address>
        <city>Riga</city>
        <zip>LV-1002-1002</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Consultorio Médico Dr. Alma Laura Ladron de Guevara</name>
      <address>
        <city>Mexico</city>
        <state>Distrito Federal</state>
        <zip>06700</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>JM Research - Cuernavaca</name>
      <address>
        <city>Cuernavaca</city>
        <state>Morelos</state>
        <zip>62290</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigaciones Medicas Cisneros</name>
      <address>
        <city>Monterrey</city>
        <state>Nuevo Leon</state>
        <zip>64000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Consultorio Dra. Maria Sarai Gonzalez Huezo</name>
      <address>
        <city>Metepec</city>
        <zip>52140</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Auckland City Hospital</name>
      <address>
        <city>Grafton</city>
        <state>Auckland</state>
        <zip>1023</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Middlemore Clinical Trials</name>
      <address>
        <city>Papatoetoe</city>
        <state>Auckland</state>
        <zip>2025</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oslo Universitetssykehus-Ullevål</name>
      <address>
        <city>Oslo</city>
        <zip>0450</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Badan Klinicznych Piotr Napora Lekarze Spólka Partnerska</name>
      <address>
        <city>Wroclaw</city>
        <state>Dolnoslaskie</state>
        <zip>51-162</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EMC Instytut Medyczny</name>
      <address>
        <city>Wroclaw</city>
        <state>Dolnoslaskie</state>
        <zip>54-144</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wojewódzki Specjalistyczny Szpital im. dr Wl. Bieganskiego w Lodzi</name>
      <address>
        <city>Lódz</city>
        <state>Lodzkie</state>
        <zip>91-347</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Polska Sp. z o.o. Oddział w Łodzi</name>
      <address>
        <city>Łódź</city>
        <state>Lodz</state>
        <zip>90-127</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Specjalistyczny Nr 1 w Bytomiu</name>
      <address>
        <city>Bytom</city>
        <state>Slaskie</state>
        <zip>41-902</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ID Clinic Arkadiusz Pisula</name>
      <address>
        <city>Myslowice</city>
        <state>Slaskie</state>
        <zip>41400-400</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Polska Sp z o o Oddzial w Poznaniu</name>
      <address>
        <city>Poznań</city>
        <state>Wielkopolska</state>
        <zip>60 702-702</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Polska Sp. z o.o. Oddzial we Wroclawiu</name>
      <address>
        <city>Wrocław</city>
        <state>Wroclaw</state>
        <zip>50-381</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Polska Sp. Z o.o. Oddzial w Czestochowie</name>
      <address>
        <city>Czestochowa</city>
        <zip>0 42-202</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Polska Sp. z o.o. Oddzial w Gdansku</name>
      <address>
        <city>Gdańsk</city>
        <zip>80-382</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Polska Sp. z o.o. Oddzial w Gdyni ul.</name>
      <address>
        <city>Gdynia</city>
        <zip>81-537</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus SCM Sp. z o.o. Oddzial</name>
      <address>
        <city>Katowice</city>
        <zip>40-040</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Polska Sp. z o.o. Oddział w Warszawie</name>
      <address>
        <city>Warsaw</city>
        <zip>01-192</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Presa-Ramos</name>
      <address>
        <city>Vila Real</city>
        <state>Lordelo</state>
        <zip>5000-508</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unidade Local de Saúde do Alto Minho</name>
      <address>
        <city>Viana do Castelo</city>
        <zip>4904-858</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Puerto Rico</name>
      <address>
        <city>San Juan</city>
        <zip>00909-1711</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundacion de Investigacion De Diego</name>
      <address>
        <city>San Juan</city>
        <zip>00927</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institutul Regional de Gastroenterologie si Hepatologie Prof. Dr. O Fodor</name>
      <address>
        <city>Cluj-Napoca</city>
        <state>Cluj</state>
        <zip>400162</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinic Professor Gorbakova</name>
      <address>
        <city>Krasnogorsk</city>
        <state>Moscow</state>
        <zip>143405</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sklifosovsky Scientific Research Institution of Emergency Care</name>
      <address>
        <city>Moscow</city>
        <zip>129090</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moscow Regional Research and Clinical Institute M.F. Vladimirsky</name>
      <address>
        <city>Moscow</city>
        <zip>129110</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National University Hospital</name>
      <address>
        <city>Singapore</city>
        <zip>119082</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Germans Trias i Pujol</name>
      <address>
        <city>Badalona</city>
        <state>Barcelona</state>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Donostia</name>
      <address>
        <city>San Sebastian</city>
        <state>Guipuzcoa</state>
        <zip>20014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario Torrecardenas</name>
      <address>
        <city>Almeria</city>
        <zip>4009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital del Mar</name>
      <address>
        <city>Barcelona</city>
        <zip>08003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Vall d'Hebrón</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario Gregorio Marañon</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Ramón Y Cajal</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico Universitario Virgen de la Victoria</name>
      <address>
        <city>Málaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Marqués de Valdecilla</name>
      <address>
        <city>Santander</city>
        <zip>39008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen del Rocio</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Nuestra Senora de Valme</name>
      <address>
        <city>Sevilla</city>
        <zip>41014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Consorci Hospital General Universitari de València</name>
      <address>
        <city>Valencia</city>
        <zip>46014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari i Politecnic La Fe de Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kantonsspital St.Gallen Klinik für</name>
      <address>
        <city>St. Gallen</city>
        <state>Saint Gallen</state>
        <zip>9007</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsspital Bern Inselspital</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chia-Yi Christian Hospital</name>
      <address>
        <city>Chiayi City</city>
        <state>Chiayi</state>
        <zip>60002</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>China Medical University Hospital</name>
      <address>
        <city>Taichung</city>
        <state>Taichung City</state>
        <zip>404</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chang Gung Medical Foundation-LinKou Branch</name>
      <address>
        <city>Taoyuan</city>
        <zip>333</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Birmingham NHS Foundation Trust</name>
      <address>
        <city>Birmingham</city>
        <state>England</state>
        <zip>B15 2TH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hull and East Yorkshire Hospitals NHS Trust</name>
      <address>
        <city>Hull</city>
        <state>England</state>
        <zip>HU3 2JZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Free London NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <state>England</state>
        <zip>NW3 2QG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kings College Hospital NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <state>England</state>
        <zip>SE5 9RS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chelsea and Westminster Hospital NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <state>England</state>
        <zip>SW10 9NH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Luton and Dunstable Hospital NHS Foundation Trust</name>
      <address>
        <city>Luton</city>
        <state>England</state>
        <zip>LU4 0DZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Newcastle Upon the Tyne Hospitals</name>
      <address>
        <city>Newcastle</city>
        <state>England</state>
        <zip>NE2 7DN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nottingham Digestive Diseases Biomedical Research Unit</name>
      <address>
        <city>Nottingham</city>
        <state>England</state>
        <zip>NG7 2UH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Plymouth Hospitals NHS Trust</name>
      <address>
        <city>Plymouth</city>
        <state>England</state>
        <zip>PL6 8DH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Stoke University Hospital</name>
      <address>
        <city>Stoke-on-Trent</city>
        <state>England</state>
        <zip>ST4 6QG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St James's University Hospital</name>
      <address>
        <city>Leeds</city>
        <state>West Yorkshire</state>
        <zip>LS97TF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Hexham Clinical Research Centre</name>
      <address>
        <city>Hexham</city>
        <zip>NE46 1QJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Lancashire Clinical Research Centre</name>
      <address>
        <city>Lancaster</city>
        <zip>PR7 7NA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barts Health NHS Trust The Royal London Hospital</name>
      <address>
        <city>London</city>
        <zip>E1 1BB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of South Manchester NHS Foundation Trust</name>
      <address>
        <city>Manchester</city>
        <zip>M23 9LT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Brazil</country>
    <country>Canada</country>
    <country>Chile</country>
    <country>France</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Hong Kong</country>
    <country>Hungary</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Latvia</country>
    <country>Mexico</country>
    <country>New Zealand</country>
    <country>Norway</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Puerto Rico</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>Singapore</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>Taiwan</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Argentina</country>
    <country>Georgia</country>
    <country>India</country>
    <country>Peru</country>
    <country>Slovenia</country>
  </removed_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <results_first_submitted>January 4, 2022</results_first_submitted>
  <results_first_submitted_qc>February 11, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">March 10, 2022</results_first_posted>
  <last_update_submitted>February 11, 2022</last_update_submitted>
  <last_update_submitted_qc>February 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatty Liver</mesh_term>
    <mesh_term>Non-alcoholic Fatty Liver Disease</mesh_term>
    <mesh_term>Liver Cirrhosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cenicriviroc</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 25, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/40/NCT03028740/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 19, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/40/NCT03028740/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>1778 participants were randomized into the study, of which 1293 participated in Part 1 of the study. The study was terminated early, and Part 2 did not enroll the planned number of participants. Therefore, the Part 1 and Part 2 data were combined and reported as the Full Study Cohort for reporting of the Part 2 efficacy endpoints and the safety endpoints.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Participants received cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months.</description>
        </group>
        <group group_id="P2">
          <title>Cenicriviroc 150 mg</title>
          <description>Participants received cenicriviroc, 150 milligrams (mg), tablet, orally, once daily for up to approximately 40 months.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="593"/>
                <participants group_id="P2" count="1185"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Full Study Cohort: Received Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="589"/>
                <participants group_id="P2" count="1180"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Participated in Part 1</title>
              <participants_list>
                <participants group_id="P1" count="432"/>
                <participants group_id="P2" count="861"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Part 1: Received Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="429"/>
                <participants group_id="P2" count="859"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="593"/>
                <participants group_id="P2" count="1185"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Did not Receive Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="26"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="48"/>
                <participants group_id="P2" count="101"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="54"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-compliance with Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study Terminated by Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="467"/>
                <participants group_id="P2" count="917"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol-specified Withdrawal Criteria Met</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="55"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Reason not Specified</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Modified Intent-to-Treat (mITT) Population for the Full Study Cohort included participants randomly assigned to a treatment group who received at least one dose of study drug in Parts 1 and 2 of the study combined.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Participants received cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months.</description>
        </group>
        <group group_id="B2">
          <title>Cenicriviroc 150 mg</title>
          <description>Participants received cenicriviroc,150 mg, tablet, orally, once daily for up to approximately 40 months.</description>
        </group>
        <group group_id="B3">
          <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="589"/>
            <count group_id="B2" value="1180"/>
            <count group_id="B3" value="1769"/>
          </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="55.8" spread="11.04"/>
                    <measurement group_id="B2" value="55.2" spread="10.76"/>
                    <measurement group_id="B3" value="55.4" spread="10.86"/>
                  </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="354"/>
                    <measurement group_id="B2" value="749"/>
                    <measurement group_id="B3" value="1103"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="235"/>
                    <measurement group_id="B2" value="431"/>
                    <measurement group_id="B3" value="666"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="172"/>
                    <measurement group_id="B2" value="315"/>
                    <measurement group_id="B3" value="487"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="417"/>
                    <measurement group_id="B2" value="865"/>
                    <measurement group_id="B3" value="1282"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="67"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="52"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="539"/>
                    <measurement group_id="B2" value="1075"/>
                    <measurement group_id="B3" value="1614"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Part 1: Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage and No Worsening of Steatohepatitis on Liver Histology at Month 12</title>
        <description>Fibrosis stage was evaluated using the Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) Fibrosis Staging System with stages: 0=none; 1=perisinusoidal or periportal; 1A=mild, zone 3, perisinusoidal; 1B=moderate, zone 3, perisinusoidal; 1C=portal/periportal; 2=perisinusoidal and portal/periportal; 3=bridging fibrosis; 4=cirrhosis. No worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade as per scoring in relevant nonalcoholic fatty liver disease activity score (NAS) categories. NAS is a semiquantitative scoring system based on the unweighted sum of: steatosis (0=&lt;5% to 3=&gt;66%), lobular inflammation (0=no foci to 3=&gt;4 foci/200x), and hepatocellular ballooning (0=none to 2=many cells/prominent ballooning) scores. Improvement in fibrosis is a decrease in the NASH CRN fibrosis stage.</description>
        <time_frame>Month 12</time_frame>
        <population>mITT Population for Part 1 included participants randomly assigned to a treatment group who received at least one dose of study drug in Part 1.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months.</description>
          </group>
          <group group_id="O2">
            <title>Cenicriviroc 150 mg</title>
            <description>Participants received cenicriviroc,150 mg, tablet, orally, once daily for up to approximately 40 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage and No Worsening of Steatohepatitis on Liver Histology at Month 12</title>
          <description>Fibrosis stage was evaluated using the Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) Fibrosis Staging System with stages: 0=none; 1=perisinusoidal or periportal; 1A=mild, zone 3, perisinusoidal; 1B=moderate, zone 3, perisinusoidal; 1C=portal/periportal; 2=perisinusoidal and portal/periportal; 3=bridging fibrosis; 4=cirrhosis. No worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade as per scoring in relevant nonalcoholic fatty liver disease activity score (NAS) categories. NAS is a semiquantitative scoring system based on the unweighted sum of: steatosis (0=&lt;5% to 3=&gt;66%), lobular inflammation (0=no foci to 3=&gt;4 foci/200x), and hepatocellular ballooning (0=none to 2=many cells/prominent ballooning) scores. Improvement in fibrosis is a decrease in the NASH CRN fibrosis stage.</description>
          <population>mITT Population for Part 1 included participants randomly assigned to a treatment group who received at least one dose of study drug in Part 1.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="429"/>
                <count group_id="O2" value="859"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.5" lower_limit="21.5" upper_limit="29.9"/>
                    <measurement group_id="O2" value="22.3" lower_limit="19.6" upper_limit="25.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2067</p_value>
            <p_value_desc>P-value was based on Cochran-Mantel-Haenszel general association test comparing Cenicriviroc vs Placebo, controlling for factors (randomization strata: fibrosis stage [2 vs 3] and presence or absence of Type 2 diabetes mellitus (T2DM) at Baseline).</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Percentage Difference</param_type>
            <param_value>-3.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.2</ci_lower_limit>
            <ci_upper_limit>1.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.8369</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.6341</ci_lower_limit>
            <ci_upper_limit>1.1044</ci_upper_limit>
            <estimate_desc>Odds Ratio was based on Mantel-Haenszel estimates comparing Cenicriviroc vs Placebo, controlling for factors (randomization strata: fibrosis stage [2 vs 3] and presence or absence of T2DM at Baseline).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Time to First Occurrence of Adjudicated Events in the Full Study Cohort</title>
        <description>Time to first occurrence from Baseline was defined as the number of days from the first dose of randomized investigational product to the onset of the first occurrence of any of the following adjudicated events: death (all cause), histopathologic progression to cirrhosis, liver transplant, model for end stage liver disease (MELD) score ≥15, ascites, hospitalization for onset of: variceal bleed, hepatic encephalopathy, spontaneous bacterial peritonitis. MELD is a scoring system for assessing the severity of chronic liver disease and uses the participant's values for total bilirubin, serum creatinine, and the international normalized ratio for prothrombin time to predict survival. MELD score ranges from 6 (less ill) to 40 (gravely ill) with scores and mortality probability being: Score 40=71.3% mortality; Scores 30-39=52.6% mortality; Scores 20-29=19.6% mortality; Scores10-19=6.0% mortality; Score 9 or less=1.9% mortality.</description>
        <time_frame>From first dose of study drug to onset of first occurrence of the event (Up to approximately 42 months)</time_frame>
        <population>mITT Population for the full study cohort included participants randomly assigned to a treatment group who received at least one dose of study drug in Parts 1 and 2 of the study combined.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months.</description>
          </group>
          <group group_id="O2">
            <title>Cenicriviroc 150 mg</title>
            <description>Participants received cenicriviroc,150 mg, tablet, orally, once daily for up to approximately 40 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to First Occurrence of Adjudicated Events in the Full Study Cohort</title>
          <description>Time to first occurrence from Baseline was defined as the number of days from the first dose of randomized investigational product to the onset of the first occurrence of any of the following adjudicated events: death (all cause), histopathologic progression to cirrhosis, liver transplant, model for end stage liver disease (MELD) score ≥15, ascites, hospitalization for onset of: variceal bleed, hepatic encephalopathy, spontaneous bacterial peritonitis. MELD is a scoring system for assessing the severity of chronic liver disease and uses the participant's values for total bilirubin, serum creatinine, and the international normalized ratio for prothrombin time to predict survival. MELD score ranges from 6 (less ill) to 40 (gravely ill) with scores and mortality probability being: Score 40=71.3% mortality; Scores 30-39=52.6% mortality; Scores 20-29=19.6% mortality; Scores10-19=6.0% mortality; Score 9 or less=1.9% mortality.</description>
          <population>mITT Population for the full study cohort included participants randomly assigned to a treatment group who received at least one dose of study drug in Parts 1 and 2 of the study combined.</population>
          <units>days</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="589"/>
                <count group_id="O2" value="1180"/>
              </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">Median, lower and upper limit of 95% confidence interval (C.I.) were not estimable due to low number of participants with events.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Median, lower and upper limit of 95% C.I. were not estimable due to low number of participants with events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 1: Percentage of Participants With Improvement in Fibrosis by at Least 2 Stages and No Worsening of Steatohepatitis on Liver Histology at Month 12</title>
        <description>Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages: 0=none; 1=perisinusoidal or periportal; 1A=mild, zone 3, perisinusoidal; 1B=moderate, zone 3, perisinusoidal; 1C=portal/periportal; 2=perisinusoidal and portal/periportal; 3=bridging fibrosis; 4=cirrhosis. No worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade as per scoring in relevant NAS categories. NAS is a semiquantitative scoring system based on the unweighted sum of: steatosis (0=&lt;5% to 3=&gt;66%), lobular inflammation (0=no foci to 3=&gt;4 foci/200x), and hepatocellular ballooning (0=none to 2=many cells/prominent ballooning) scores. Improvement in fibrosis is a decrease in the NASH CRN fibrosis stage.</description>
        <time_frame>Month 12</time_frame>
        <population>mITT Population for Part 1 included participants randomly assigned to a treatment group who received at least one dose of study drug in Part 1.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months.</description>
          </group>
          <group group_id="O2">
            <title>Cenicriviroc 150 mg</title>
            <description>Participants received cenicriviroc,150 mg, tablet, orally, once daily for up to approximately 40 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Percentage of Participants With Improvement in Fibrosis by at Least 2 Stages and No Worsening of Steatohepatitis on Liver Histology at Month 12</title>
          <description>Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages: 0=none; 1=perisinusoidal or periportal; 1A=mild, zone 3, perisinusoidal; 1B=moderate, zone 3, perisinusoidal; 1C=portal/periportal; 2=perisinusoidal and portal/periportal; 3=bridging fibrosis; 4=cirrhosis. No worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade as per scoring in relevant NAS categories. NAS is a semiquantitative scoring system based on the unweighted sum of: steatosis (0=&lt;5% to 3=&gt;66%), lobular inflammation (0=no foci to 3=&gt;4 foci/200x), and hepatocellular ballooning (0=none to 2=many cells/prominent ballooning) scores. Improvement in fibrosis is a decrease in the NASH CRN fibrosis stage.</description>
          <population>mITT Population for Part 1 included participants randomly assigned to a treatment group who received at least one dose of study drug in Part 1.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="429"/>
                <count group_id="O2" value="859"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.3" lower_limit="6.0" upper_limit="11.3"/>
                    <measurement group_id="O2" value="6.6" lower_limit="5.1" upper_limit="8.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2827</p_value>
            <p_value_desc>P-value was based on Cochran-Mantel-Haenszel general association test comparing Cenicriviroc vs Placebo, controlling for factors (randomization strata: fibrosis stage [2 vs 3] and presence or absence of T2DM at Baseline).</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Percentage Difference</param_type>
            <param_value>-1.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.8</ci_lower_limit>
            <ci_upper_limit>1.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.7844</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.5032</ci_lower_limit>
            <ci_upper_limit>1.2229</ci_upper_limit>
            <estimate_desc>Odds Ratio was based on Mantel-Haenszel estimates comparing Cenicriviroc vs Placebo, controlling for factors (randomization strata: fibrosis stage [2 vs 3] and presence or absence of T2DM at Baseline).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 1: Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage Regardless of Effect on Steatohepatitis at Month 12</title>
        <description>Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages 0=none, 1=perisinusoidal or periportal, 1A=mild, zone 3, perisinusoidal, 1B=moderate, zone 3, perisinusoidal, 1C=portal/periportal, 2=perisinusoidal and portal/periportal, 3=bridging fibrosis, 4=cirrhosis.</description>
        <time_frame>Month 12</time_frame>
        <population>mITT Population for Part 1 included participants randomly assigned to a treatment group who received at least one dose of study drug in Part 1. Overall number analyzed is the number of participants with data available for analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months.</description>
          </group>
          <group group_id="O2">
            <title>Cenicriviroc 150 mg</title>
            <description>Participants received cenicriviroc, 150 mg, tablet, orally, once daily for up to approximately 40 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage Regardless of Effect on Steatohepatitis at Month 12</title>
          <description>Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages 0=none, 1=perisinusoidal or periportal, 1A=mild, zone 3, perisinusoidal, 1B=moderate, zone 3, perisinusoidal, 1C=portal/periportal, 2=perisinusoidal and portal/periportal, 3=bridging fibrosis, 4=cirrhosis.</description>
          <population>mITT Population for Part 1 included participants randomly assigned to a treatment group who received at least one dose of study drug in Part 1. Overall number analyzed is the number of participants with data available for analyses.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="348"/>
                <count group_id="O2" value="692"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3" lower_limit="28.6" upper_limit="38.4"/>
                    <measurement group_id="O2" value="30.6" lower_limit="27.3" upper_limit="34.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4054</p_value>
            <p_value_desc>P-value was based on Cochran-Mantel-Haenszel general association test comparing Cenicriviroc vs Placebo, controlling for factors (randomization strata: fibrosis stage [2 vs 3] and presence or absence of T2DM at Baseline).</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Percentage Difference</param_type>
            <param_value>-2.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.7</ci_lower_limit>
            <ci_upper_limit>3.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.8877</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.6709</ci_lower_limit>
            <ci_upper_limit>1.1744</ci_upper_limit>
            <estimate_desc>Odds Ratio was based on Mantel-Haenszel estimates comparing Cenicriviroc vs Placebo, controlling for factors (randomization strata: fibrosis stage [2 vs 3] and presence or absence of T2DM at Baseline).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 1: Percentage of Participants With Improvement in Fibrosis by at Least 2 Stages Regardless of Effect on Steatohepatitis at Month 12</title>
        <description>Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages 0=none, 1=perisinusoidal or periportal, 1A=mild, zone 3, perisinusoidal, 1B=moderate, zone 3, perisinusoidal, 1C=portal/periportal, 2=perisinusoidal and portal/periportal, 3=bridging fibrosis, 4=cirrhosis.</description>
        <time_frame>Month 12</time_frame>
        <population>mITT Population for Part 1 included participants randomly assigned to a treatment group who received at least one dose of study drug in Part 1. Overall number analyzed is the number of participants with data available for analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months.</description>
          </group>
          <group group_id="O2">
            <title>Cenicriviroc 150 mg</title>
            <description>Participants received cenicriviroc, 150 mg, tablet, orally, once daily for up to approximately 40 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Percentage of Participants With Improvement in Fibrosis by at Least 2 Stages Regardless of Effect on Steatohepatitis at Month 12</title>
          <description>Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages 0=none, 1=perisinusoidal or periportal, 1A=mild, zone 3, perisinusoidal, 1B=moderate, zone 3, perisinusoidal, 1C=portal/periportal, 2=perisinusoidal and portal/periportal, 3=bridging fibrosis, 4=cirrhosis.</description>
          <population>mITT Population for Part 1 included participants randomly assigned to a treatment group who received at least one dose of study drug in Part 1. Overall number analyzed is the number of participants with data available for analyses.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="348"/>
                <count group_id="O2" value="692"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.3"/>
                    <measurement group_id="O2" value="8.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage and No Worsening of Steatohepatitis on Liver Biopsy at Month 12 in the Full Study Cohort</title>
        <description>Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages: 0=none; 1=perisinusoidal or periportal; 1A=mild, zone 3, perisinusoidal; 1B=moderate, zone 3, perisinusoidal; 1C=portal/periportal; 2=perisinusoidal and portal/periportal; 3=bridging fibrosis; 4=cirrhosis. No worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade as per scoring in relevant NAS categories. NAS is a semiquantitative scoring system based on the unweighted sum of: steatosis (0=&lt;5% to 3=&gt;66%), lobular inflammation (0=no foci to 3=&gt;4 foci/200x), and hepatocellular ballooning (0=none to 2=many cells/prominent ballooning) scores. Improvement in fibrosis is a decrease in the NASH CRN fibrosis stage.</description>
        <time_frame>Month 12</time_frame>
        <population>mITT Population for the full study cohort included participants randomly assigned to a treatment group who received at least one dose of study drug in Parts 1 and 2 of the study combined.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months.</description>
          </group>
          <group group_id="O2">
            <title>Cenicriviroc 150 mg</title>
            <description>Participants received cenicriviroc,150 mg, tablet, orally, once daily for up to approximately 40 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage and No Worsening of Steatohepatitis on Liver Biopsy at Month 12 in the Full Study Cohort</title>
          <description>Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages: 0=none; 1=perisinusoidal or periportal; 1A=mild, zone 3, perisinusoidal; 1B=moderate, zone 3, perisinusoidal; 1C=portal/periportal; 2=perisinusoidal and portal/periportal; 3=bridging fibrosis; 4=cirrhosis. No worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade as per scoring in relevant NAS categories. NAS is a semiquantitative scoring system based on the unweighted sum of: steatosis (0=&lt;5% to 3=&gt;66%), lobular inflammation (0=no foci to 3=&gt;4 foci/200x), and hepatocellular ballooning (0=none to 2=many cells/prominent ballooning) scores. Improvement in fibrosis is a decrease in the NASH CRN fibrosis stage.</description>
          <population>mITT Population for the full study cohort included participants randomly assigned to a treatment group who received at least one dose of study drug in Parts 1 and 2 of the study combined.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="589"/>
                <count group_id="O2" value="1180"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.0" lower_limit="21.2" upper_limit="29.2"/>
                    <measurement group_id="O2" value="22.0" lower_limit="19.4" upper_limit="24.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage Regardless of Effect on Steatohepatitis on Liver Biopsy at Month 12 in the Full Study Cohort</title>
        <description>Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages 0=none, 1=perisinusoidal or periportal, 1A=mild, zone 3, perisinusoidal, 1B=moderate, zone 3, perisinusoidal, 1C=portal/periportal, 2=perisinusoidal and portal/periportal, 3=bridging fibrosis, 4=cirrhosis.</description>
        <time_frame>Month 12</time_frame>
        <population>mITT Population for the full study cohort included participants randomly assigned to a treatment group who received at least one dose of study drug in Parts 1 and 2 of the study combined. Overall number analyzed is the number of participants with data available for analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Drug: Placebo</title>
            <description>Participants received cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months.</description>
          </group>
          <group group_id="O2">
            <title>Drug: Cenicriviroc 150 mg</title>
            <description>Participants received cenicriviroc, 150 mg, tablet, orally, once daily for up to approximately 40 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage Regardless of Effect on Steatohepatitis on Liver Biopsy at Month 12 in the Full Study Cohort</title>
          <description>Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages 0=none, 1=perisinusoidal or periportal, 1A=mild, zone 3, perisinusoidal, 1B=moderate, zone 3, perisinusoidal, 1C=portal/periportal, 2=perisinusoidal and portal/periportal, 3=bridging fibrosis, 4=cirrhosis.</description>
          <population>mITT Population for the full study cohort included participants randomly assigned to a treatment group who received at least one dose of study drug in Parts 1 and 2 of the study combined. Overall number analyzed is the number of participants with data available for analyses.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="373"/>
                <count group_id="O2" value="741"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.2" lower_limit="28.7" upper_limit="38.2"/>
                    <measurement group_id="O2" value="30.5" lower_limit="27.3" upper_limit="33.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Improvement in Fibrosis by at Least 2 Stages and No Worsening of Steatohepatitis on Liver Biopsy at Month 12 in the Full Study Cohort</title>
        <description>Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages: 0=none; 1=perisinusoidal or periportal; 1A=mild, zone 3, perisinusoidal; 1B=moderate, zone 3, perisinusoidal; 1C=portal/periportal; 2=perisinusoidal and portal/periportal; 3=bridging fibrosis; 4=cirrhosis. No worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade as per scoring in relevant NAS categories. NAS is a semiquantitative scoring system based on the unweighted sum of: steatosis (0=&lt;5% to 3=&gt;66%), lobular inflammation (0=no foci to 3=&gt;4 foci/200x), and hepatocellular ballooning (0=none to 2=many cells/prominent ballooning) scores. Improvement in fibrosis is a decrease in the NASH CRN fibrosis stage.</description>
        <time_frame>Month 12</time_frame>
        <population>mITT Population for the full study cohort included participants randomly assigned to a treatment group who received at least one dose of study drug for Parts 1 and 2 of the study combined.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months.</description>
          </group>
          <group group_id="O2">
            <title>Cenicriviroc 150 mg</title>
            <description>Participants received cenicriviroc,150 mg, tablet, orally, once daily for up to approximately 40 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Improvement in Fibrosis by at Least 2 Stages and No Worsening of Steatohepatitis on Liver Biopsy at Month 12 in the Full Study Cohort</title>
          <description>Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages: 0=none; 1=perisinusoidal or periportal; 1A=mild, zone 3, perisinusoidal; 1B=moderate, zone 3, perisinusoidal; 1C=portal/periportal; 2=perisinusoidal and portal/periportal; 3=bridging fibrosis; 4=cirrhosis. No worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade as per scoring in relevant NAS categories. NAS is a semiquantitative scoring system based on the unweighted sum of: steatosis (0=&lt;5% to 3=&gt;66%), lobular inflammation (0=no foci to 3=&gt;4 foci/200x), and hepatocellular ballooning (0=none to 2=many cells/prominent ballooning) scores. Improvement in fibrosis is a decrease in the NASH CRN fibrosis stage.</description>
          <population>mITT Population for the full study cohort included participants randomly assigned to a treatment group who received at least one dose of study drug for Parts 1 and 2 of the study combined.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="589"/>
                <count group_id="O2" value="1180"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.3" lower_limit="5.9" upper_limit="11.1"/>
                    <measurement group_id="O2" value="6.8" lower_limit="5.2" upper_limit="8.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Improvement in Fibrosis by at Least 2 Stages Regardless of Effect on Steatohepatitis on Liver Biopsy at Month 12 in the Full Study Cohort</title>
        <description>Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages 0=none, 1=perisinusoidal or periportal, 1A=mild, zone 3, perisinusoidal, 1B=moderate, zone 3, perisinusoidal, 1C=portal/periportal, 2=perisinusoidal and portal/periportal, 3=bridging fibrosis, 4=cirrhosis.</description>
        <time_frame>Month 12</time_frame>
        <population>mITT Population for the full study cohort included participants randomly assigned to a treatment group who received at least one dose of study drug in Parts 1 and 2 of the study combined. Overall number analyzed is the number of participants with data available for analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months.</description>
          </group>
          <group group_id="O2">
            <title>Cenicriviroc 150 mg</title>
            <description>Participants received cenicriviroc, 150 mg, tablet, orally, once daily for up to approximately 40 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Improvement in Fibrosis by at Least 2 Stages Regardless of Effect on Steatohepatitis on Liver Biopsy at Month 12 in the Full Study Cohort</title>
          <description>Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages 0=none, 1=perisinusoidal or periportal, 1A=mild, zone 3, perisinusoidal, 1B=moderate, zone 3, perisinusoidal, 1C=portal/periportal, 2=perisinusoidal and portal/periportal, 3=bridging fibrosis, 4=cirrhosis.</description>
          <population>mITT Population for the full study cohort included participants randomly assigned to a treatment group who received at least one dose of study drug in Parts 1 and 2 of the study combined. Overall number analyzed is the number of participants with data available for analyses.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="373"/>
                <count group_id="O2" value="741"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.9"/>
                    <measurement group_id="O2" value="8.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage and No Worsening of Steatohepatitis on Liver Biopsy at Month 60 in the Full Study Cohort</title>
        <description>Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages: 0=none; 1=perisinusoidal or periportal; 1A=mild, zone 3, perisinusoidal; 1B=moderate, zone 3, perisinusoidal; 1C=portal/periportal; 2=perisinusoidal and portal/periportal; 3=bridging fibrosis; 4=cirrhosis. No worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade as per scoring in relevant NAS categories. NAS is a semiquantitative scoring system based on the unweighted sum of: steatosis (0=&lt;5% to 3=&gt;66%), lobular inflammation (0=no foci to 3=&gt;4 foci/200x), and hepatocellular ballooning (0=none to 2=many cells/prominent ballooning) scores. Improvement in fibrosis is a decrease in the NASH CRN fibrosis stage.</description>
        <time_frame>Month 60</time_frame>
        <population>No data was collected as the study was terminated and no participants reached the Month 60 timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months.</description>
          </group>
          <group group_id="O2">
            <title>Cenicriviroc 150 mg</title>
            <description>Participants received cenicriviroc, 150 mg, tablet, orally, once daily for up to approximately 40 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage and No Worsening of Steatohepatitis on Liver Biopsy at Month 60 in the Full Study Cohort</title>
          <description>Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages: 0=none; 1=perisinusoidal or periportal; 1A=mild, zone 3, perisinusoidal; 1B=moderate, zone 3, perisinusoidal; 1C=portal/periportal; 2=perisinusoidal and portal/periportal; 3=bridging fibrosis; 4=cirrhosis. No worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade as per scoring in relevant NAS categories. NAS is a semiquantitative scoring system based on the unweighted sum of: steatosis (0=&lt;5% to 3=&gt;66%), lobular inflammation (0=no foci to 3=&gt;4 foci/200x), and hepatocellular ballooning (0=none to 2=many cells/prominent ballooning) scores. Improvement in fibrosis is a decrease in the NASH CRN fibrosis stage.</description>
          <population>No data was collected as the study was terminated and no participants reached the Month 60 timepoint.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage Regardless of Effect on Steatohepatitis on Liver Biopsy at Month 60 in the Full Study Cohort</title>
        <description>Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages 0=none, 1=perisinusoidal or periportal, 1A=mild, zone 3, perisinusoidal, 1B=moderate, zone 3, perisinusoidal, 1C=portal/periportal, 2=perisinusoidal and portal/periportal, 3=bridging fibrosis, 4=cirrhosis.</description>
        <time_frame>Month 60</time_frame>
        <population>No data was collected as the study was terminated and no participants reached the Month 60 timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months.</description>
          </group>
          <group group_id="O2">
            <title>Cenicriviroc 150 mg</title>
            <description>Participants received cenicriviroc, 150 mg, tablet, orally, once daily for up to approximately 40 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage Regardless of Effect on Steatohepatitis on Liver Biopsy at Month 60 in the Full Study Cohort</title>
          <description>Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages 0=none, 1=perisinusoidal or periportal, 1A=mild, zone 3, perisinusoidal, 1B=moderate, zone 3, perisinusoidal, 1C=portal/periportal, 2=perisinusoidal and portal/periportal, 3=bridging fibrosis, 4=cirrhosis.</description>
          <population>No data was collected as the study was terminated and no participants reached the Month 60 timepoint.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Improvement in Fibrosis by at Least 2 Stages and No Worsening of Steatohepatitis on Liver Biopsy at Month 60 in the Full Study Cohort</title>
        <description>Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages: 0=none; 1=perisinusoidal or periportal; 1A=mild, zone 3, perisinusoidal; 1B=moderate, zone 3, perisinusoidal; 1C=portal/periportal; 2=perisinusoidal and portal/periportal; 3=bridging fibrosis; 4=cirrhosis. No worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade as per scoring in relevant NAS categories. NAS is a semiquantitative scoring system based on the unweighted sum of: steatosis (0=&lt;5% to 3=&gt;66%), lobular inflammation (0=no foci to 3=&gt;4 foci/200x), and hepatocellular ballooning (0=none to 2=many cells/prominent ballooning) scores. Improvement in fibrosis is a decrease in the NASH CRN fibrosis stage.</description>
        <time_frame>Month 60</time_frame>
        <population>No data was collected as the study was terminated and no participants reached the Month 60 timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months.</description>
          </group>
          <group group_id="O2">
            <title>Cenicriviroc 150 mg</title>
            <description>Participants received cenicriviroc, 150 mg, tablet, orally, once daily for up to approximately 40 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Improvement in Fibrosis by at Least 2 Stages and No Worsening of Steatohepatitis on Liver Biopsy at Month 60 in the Full Study Cohort</title>
          <description>Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages: 0=none; 1=perisinusoidal or periportal; 1A=mild, zone 3, perisinusoidal; 1B=moderate, zone 3, perisinusoidal; 1C=portal/periportal; 2=perisinusoidal and portal/periportal; 3=bridging fibrosis; 4=cirrhosis. No worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade as per scoring in relevant NAS categories. NAS is a semiquantitative scoring system based on the unweighted sum of: steatosis (0=&lt;5% to 3=&gt;66%), lobular inflammation (0=no foci to 3=&gt;4 foci/200x), and hepatocellular ballooning (0=none to 2=many cells/prominent ballooning) scores. Improvement in fibrosis is a decrease in the NASH CRN fibrosis stage.</description>
          <population>No data was collected as the study was terminated and no participants reached the Month 60 timepoint.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Improvement in Fibrosis by at Least 2 Stages Regardless of Effect on Steatohepatitis on Liver Biopsy at Month 60 in the Full Study Cohort</title>
        <description>Fibrosis stage was evaluated using NASH CRN Fibrosis Staging System with stages 0=None, 1=Perisinusoidal or periportal, 1A=Mild, zone 3, perisinusoidal, 1B=Moderate, zone 3, perisinusoidal, 1C=Portal/periportal, 2=Perisinusoidal and portal/periportal, 3=Bridging fibrosis, 4=Cirrhosis.</description>
        <time_frame>Month 60</time_frame>
        <population>No data was collected as the study was terminated and no participants reached the Month 60 timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months.</description>
          </group>
          <group group_id="O2">
            <title>Cenicriviroc 150 mg</title>
            <description>Participants received cenicriviroc, 150 mg, tablet, orally, once daily for up to approximately 40 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Improvement in Fibrosis by at Least 2 Stages Regardless of Effect on Steatohepatitis on Liver Biopsy at Month 60 in the Full Study Cohort</title>
          <description>Fibrosis stage was evaluated using NASH CRN Fibrosis Staging System with stages 0=None, 1=Perisinusoidal or periportal, 1A=Mild, zone 3, perisinusoidal, 1B=Moderate, zone 3, perisinusoidal, 1C=Portal/periportal, 2=Perisinusoidal and portal/periportal, 3=Bridging fibrosis, 4=Cirrhosis.</description>
          <population>No data was collected as the study was terminated and no participants reached the Month 60 timepoint.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From first dose through 30 days after the last dose of study drug (Up to approximately 42 months)</time_frame>
      <desc>All-cause Mortality: All enrolled participants. Serious Adverse Events and Other Adverse Events: Safety Population for the full study cohort included participants who received at least one dose of study drug in Parts 1 and 2 of the study combined.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Participants received cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months.</description>
        </group>
        <group group_id="E2">
          <title>Cenicriviroc 150 mg</title>
          <description>Participants received cenicriviroc,150 mg, tablet, orally, once daily for up to approximately 40 months.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 22.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="593"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="1185"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="70" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="159" subjects_at_risk="1180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Blood loss anaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Immune thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Lymphadenitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Splenomegaly</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </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="2" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Aortic valve incompetence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Aortic valve disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Aortic valve disease mixed</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Left ventricular hypertrophy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Mitral valve incompetence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Pulseless electrical activity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Stress cardiomyopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Coronary artery stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Phimosis</sub_title>
                <description>Number of participants at risk in each arm is based on the male population.</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="235"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="431"/>
              </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="589"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Vertigo positional</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoparathyroidism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Thyroid mass</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Visual impairment</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Diverticular perforation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Abdominal hernia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Alcoholic pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Hiatus hernia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Impaired gastric emptying</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Mesenteric panniculitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Generalised oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Systemic inflammatory response syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Autoimmune hepatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Hepatic cirrhosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Non-alcoholic steatohepatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>COVID-19 pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Acute sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Gallbladder empyema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Gangrene</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Kidney infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Post procedural infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Postoperative abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Pulmonary sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Pyelonephritis acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Rhinovirus infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Streptococcal sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Tooth abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Abdominal infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Atypical pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Cholecystitis infective</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Empyema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Herpes zoster oticus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Perineal abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Vulval cellulitis</sub_title>
                <description>Number of participants at risk in each arm is based on the female population.</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="749"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Post procedural haematoma</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Tibia fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Multiple injuries</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Animal bite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Craniocerebral injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Fibula fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Post procedural contusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Post procedural hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Tendon rupture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Thoracic vertebral fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Wrist fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Ankle fracture</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Anaemia postoperative</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Femoral neck fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Post procedural complication</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Post procedural discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Snake bite</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>SARS-CoV-2 test positive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Serum ferritin increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Blood uric acid increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Alkalosis hypochloraemic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Alkalosis hypokalaemic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Diabetic ketoacidosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Type 2 diabetes mellitus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus inadequate control</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Obesity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </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="589"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Intervertebral disc degeneration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Facet joint syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Intervertebral disc displacement</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Lumbar spinal stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Mixed connective tissue disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Myositis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Cervical spinal stenosis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Chest wall haematoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Exostosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Systemic lupus erythematosus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Tendonitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Squamous cell carcinoma of skin</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <description>Number of participants at risk in each arm is based on the male population.</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="235"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="431"/>
              </event>
              <event>
                <sub_title>Acoustic neuroma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Adenocarcinoma pancreas</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Basosquamous carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Bile duct cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Bladder transitional cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Bowen's disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Brain neoplasm benign</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Endometrial neoplasm</sub_title>
                <description>Number of participants at risk in each arm is based on the female population.</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="749"/>
              </event>
              <event>
                <sub_title>Hepatic cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Intraductal proliferative breast lesion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Invasive ductal breast carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Leiomyosarcoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Malignant melanoma of eyelid</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Non-small cell lung cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Pancreatic neuroendocrine tumour</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Papillary thyroid cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Pituitary tumour benign</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Plasma cell myeloma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Renal cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Hepatocellular carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Pancreatic carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Brain neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Endometrial cancer</sub_title>
                <description>Number of participants at risk in each arm is based on the female population.</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="749"/>
              </event>
              <event>
                <sub_title>Malignant melanoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Tumour of ampulla of Vater</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Loss of consciousness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Brain stem infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Cervical radiculopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Facial paralysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Radial nerve palsy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Coma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Hypersomnia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Lethargy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Ruptured ectopic pregnancy</sub_title>
                <description>Number of participants at risk in each arm is based on the female population.</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="749"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device dislocation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Mental status changes</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Psychiatric decompensation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Suicide attempt</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Renal colic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Ureterolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Urinary tract obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Benign prostatic hyperplasia</sub_title>
                <description>Number of participants at risk in each arm is based on the male population.</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="235"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="431"/>
              </event>
              <event>
                <sub_title>Metrorrhagia</sub_title>
                <description>Number of participants at risk in each arm is based on the female population.</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="749"/>
              </event>
              <event>
                <sub_title>Polycystic ovaries</sub_title>
                <description>Number of participants at risk in each arm is based on the female population.</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="749"/>
              </event>
              <event>
                <sub_title>Endometrial hyperplasia</sub_title>
                <description>Number of participants at risk in each arm is based on the female population.</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="749"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Acute respiratory distress syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Respiratory distress</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Sleep apnoea syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Haemothorax</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash erythematous</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Diabetic foot</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Phlebolith</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1180"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 22.1</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="218" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="425" subjects_at_risk="1180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="39" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="104" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="56" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="92" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="64" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="56" subjects_at_risk="1180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="33" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="74" subjects_at_risk="1180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="33" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="57" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="39" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="41" subjects_at_risk="1180"/>
              </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="35" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="68" subjects_at_risk="1180"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="36" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="54" subjects_at_risk="1180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="589"/>
                <counts group_id="E2" subjects_affected="64" subjects_at_risk="1180"/>
              </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>A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Therapeutic Area, Head</name_or_title>
      <organization>Allergan</organization>
      <phone>714-246-4500</phone>
      <email>clinicaltrials@allergan.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/NCT03028740
org study id: 3152-301-002
secondary id: 2016-004566-26
secondary id: 1001
nct id: NCT03028740
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The AURORA study will be conducted to confirm the efficacy and safety of cenicriviroc (CVC)
      for the treatment of liver fibrosis in adult participants with NASH.
The AURORA study will be conducted in 2 parts. Part 1 will examine the surrogate endpoint of
      improvement in fibrosis of at least 1 stage (nonalcoholic steatohepatitis clinical research
      network [NASH CRN]) and no worsening of steatohepatitis at Month 12. Participants from Part 1
      will continue into Part 2 and additional participants will be newly randomized in Part 2 to
      determine long-term clinical outcomes composed of histopathologic progression to cirrhosis,
      liver-related clinical outcomes, and all-cause mortality.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Part 1: Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage and No Worsening of Steatohepatitis on Liver Histology at Month 12
time frame: Month 12
description: Fibrosis stage was evaluated using the Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) Fibrosis Staging System with stages: 0=none; 1=perisinusoidal or periportal; 1A=mild, zone 3, perisinusoidal; 1B=moderate, zone 3, perisinusoidal; 1C=portal/periportal; 2=perisinusoidal and portal/periportal; 3=bridging fibrosis; 4=cirrhosis. No worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade as per scoring in relevant nonalcoholic fatty liver disease activity score (NAS) categories. NAS is a semiquantitative scoring system based on the unweighted sum of: steatosis (0=<5% to 3=>66%), lobular inflammation (0=no foci to 3=>4 foci/200x), and hepatocellular ballooning (0=none to 2=many cells/prominent ballooning) scores. Improvement in fibrosis is a decrease in the NASH CRN fibrosis stage.
measure: Time to First Occurrence of Adjudicated Events in the Full Study Cohort
time frame: From first dose of study drug to onset of first occurrence of the event (Up to approximately 42 months)
description: Time to first occurrence from Baseline was defined as the number of days from the first dose of randomized investigational product to the onset of the first occurrence of any of the following adjudicated events: death (all cause), histopathologic progression to cirrhosis, liver transplant, model for end stage liver disease (MELD) score ≥15, ascites, hospitalization for onset of: variceal bleed, hepatic encephalopathy, spontaneous bacterial peritonitis. MELD is a scoring system for assessing the severity of chronic liver disease and uses the participant's values for total bilirubin, serum creatinine, and the international normalized ratio for prothrombin time to predict survival. MELD score ranges from 6 (less ill) to 40 (gravely ill) with scores and mortality probability being: Score 40=71.3% mortality; Scores 30-39=52.6% mortality; Scores 20-29=19.6% mortality; Scores10-19=6.0% mortality; Score 9 or less=1.9% mortality.
measure: Part 1: Percentage of Participants With Improvement in Fibrosis by at Least 2 Stages and No Worsening of Steatohepatitis on Liver Histology at Month 12
time frame: Month 12
description: Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages: 0=none; 1=perisinusoidal or periportal; 1A=mild, zone 3, perisinusoidal; 1B=moderate, zone 3, perisinusoidal; 1C=portal/periportal; 2=perisinusoidal and portal/periportal; 3=bridging fibrosis; 4=cirrhosis. No worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade as per scoring in relevant NAS categories. NAS is a semiquantitative scoring system based on the unweighted sum of: steatosis (0=<5% to 3=>66%), lobular inflammation (0=no foci to 3=>4 foci/200x), and hepatocellular ballooning (0=none to 2=many cells/prominent ballooning) scores. Improvement in fibrosis is a decrease in the NASH CRN fibrosis stage.
measure: Part 1: Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage Regardless of Effect on Steatohepatitis at Month 12
time frame: Month 12
description: Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages 0=none, 1=perisinusoidal or periportal, 1A=mild, zone 3, perisinusoidal, 1B=moderate, zone 3, perisinusoidal, 1C=portal/periportal, 2=perisinusoidal and portal/periportal, 3=bridging fibrosis, 4=cirrhosis.
measure: Part 1: Percentage of Participants With Improvement in Fibrosis by at Least 2 Stages Regardless of Effect on Steatohepatitis at Month 12
time frame: Month 12
description: Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages 0=none, 1=perisinusoidal or periportal, 1A=mild, zone 3, perisinusoidal, 1B=moderate, zone 3, perisinusoidal, 1C=portal/periportal, 2=perisinusoidal and portal/periportal, 3=bridging fibrosis, 4=cirrhosis.
measure: Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage and No Worsening of Steatohepatitis on Liver Biopsy at Month 12 in the Full Study Cohort
time frame: Month 12
description: Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages: 0=none; 1=perisinusoidal or periportal; 1A=mild, zone 3, perisinusoidal; 1B=moderate, zone 3, perisinusoidal; 1C=portal/periportal; 2=perisinusoidal and portal/periportal; 3=bridging fibrosis; 4=cirrhosis. No worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade as per scoring in relevant NAS categories. NAS is a semiquantitative scoring system based on the unweighted sum of: steatosis (0=<5% to 3=>66%), lobular inflammation (0=no foci to 3=>4 foci/200x), and hepatocellular ballooning (0=none to 2=many cells/prominent ballooning) scores. Improvement in fibrosis is a decrease in the NASH CRN fibrosis stage.
measure: Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage Regardless of Effect on Steatohepatitis on Liver Biopsy at Month 12 in the Full Study Cohort
time frame: Month 12
description: Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages 0=none, 1=perisinusoidal or periportal, 1A=mild, zone 3, perisinusoidal, 1B=moderate, zone 3, perisinusoidal, 1C=portal/periportal, 2=perisinusoidal and portal/periportal, 3=bridging fibrosis, 4=cirrhosis.
measure: Percentage of Participants With Improvement in Fibrosis by at Least 2 Stages and No Worsening of Steatohepatitis on Liver Biopsy at Month 12 in the Full Study Cohort
time frame: Month 12
description: Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages: 0=none; 1=perisinusoidal or periportal; 1A=mild, zone 3, perisinusoidal; 1B=moderate, zone 3, perisinusoidal; 1C=portal/periportal; 2=perisinusoidal and portal/periportal; 3=bridging fibrosis; 4=cirrhosis. No worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade as per scoring in relevant NAS categories. NAS is a semiquantitative scoring system based on the unweighted sum of: steatosis (0=<5% to 3=>66%), lobular inflammation (0=no foci to 3=>4 foci/200x), and hepatocellular ballooning (0=none to 2=many cells/prominent ballooning) scores. Improvement in fibrosis is a decrease in the NASH CRN fibrosis stage.
measure: Percentage of Participants With Improvement in Fibrosis by at Least 2 Stages Regardless of Effect on Steatohepatitis on Liver Biopsy at Month 12 in the Full Study Cohort
time frame: Month 12
description: Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages 0=none, 1=perisinusoidal or periportal, 1A=mild, zone 3, perisinusoidal, 1B=moderate, zone 3, perisinusoidal, 1C=portal/periportal, 2=perisinusoidal and portal/periportal, 3=bridging fibrosis, 4=cirrhosis.
measure: Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage and No Worsening of Steatohepatitis on Liver Biopsy at Month 60 in the Full Study Cohort
time frame: Month 60
description: Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages: 0=none; 1=perisinusoidal or periportal; 1A=mild, zone 3, perisinusoidal; 1B=moderate, zone 3, perisinusoidal; 1C=portal/periportal; 2=perisinusoidal and portal/periportal; 3=bridging fibrosis; 4=cirrhosis. No worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade as per scoring in relevant NAS categories. NAS is a semiquantitative scoring system based on the unweighted sum of: steatosis (0=<5% to 3=>66%), lobular inflammation (0=no foci to 3=>4 foci/200x), and hepatocellular ballooning (0=none to 2=many cells/prominent ballooning) scores. Improvement in fibrosis is a decrease in the NASH CRN fibrosis stage.
measure: Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage Regardless of Effect on Steatohepatitis on Liver Biopsy at Month 60 in the Full Study Cohort
time frame: Month 60
description: Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages 0=none, 1=perisinusoidal or periportal, 1A=mild, zone 3, perisinusoidal, 1B=moderate, zone 3, perisinusoidal, 1C=portal/periportal, 2=perisinusoidal and portal/periportal, 3=bridging fibrosis, 4=cirrhosis.
measure: Percentage of Participants With Improvement in Fibrosis by at Least 2 Stages and No Worsening of Steatohepatitis on Liver Biopsy at Month 60 in the Full Study Cohort
time frame: Month 60
description: Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages: 0=none; 1=perisinusoidal or periportal; 1A=mild, zone 3, perisinusoidal; 1B=moderate, zone 3, perisinusoidal; 1C=portal/periportal; 2=perisinusoidal and portal/periportal; 3=bridging fibrosis; 4=cirrhosis. No worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade as per scoring in relevant NAS categories. NAS is a semiquantitative scoring system based on the unweighted sum of: steatosis (0=<5% to 3=>66%), lobular inflammation (0=no foci to 3=>4 foci/200x), and hepatocellular ballooning (0=none to 2=many cells/prominent ballooning) scores. Improvement in fibrosis is a decrease in the NASH CRN fibrosis stage.
measure: Percentage of Participants With Improvement in Fibrosis by at Least 2 Stages Regardless of Effect on Steatohepatitis on Liver Biopsy at Month 60 in the Full Study Cohort
time frame: Month 60
description: Fibrosis stage was evaluated using NASH CRN Fibrosis Staging System with stages 0=None, 1=Perisinusoidal or periportal, 1A=Mild, zone 3, perisinusoidal, 1B=Moderate, zone 3, perisinusoidal, 1C=Portal/periportal, 2=Perisinusoidal and portal/periportal, 3=Bridging fibrosis, 4=Cirrhosis.
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants received cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months.
arm group label: Cenicriviroc 150 mg
arm group type: Experimental
description: Participants received cenicriviroc, 150 milligrams (mg), tablet, orally, once daily for up to approximately 40 months.
intervention type: Drug
intervention name: Placebo
description: Cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months.
arm group label: Placebo
intervention type: Drug
intervention name: Cenicriviroc
description: Cenicriviroc, 150 mg, tablet, orally, once daily for up to approximately 40 months.
arm group label: Cenicriviroc 150 mg
other name: CVC
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Gerardo Rodriguez
role: Study Director
affiliation: Allergan
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country: Australia
country: Austria
country: Belgium
country: Brazil
country: Canada
country: Chile
country: France
country: Germany
country: Greece
country: Hong Kong
country: Hungary
country: Israel
country: Italy
country: Latvia
country: Mexico
country: New Zealand
country: Norway
country: Poland
country: Portugal
country: Puerto Rico
country: Romania
country: Russian Federation
country: Singapore
country: Spain
country: Switzerland
country: Taiwan
country: United Kingdom
country: United States
country: Argentina
country: Georgia
country: India
country: Peru
country: Slovenia
responsible party type: Sponsor
mesh term: Fatty Liver
mesh term: Non-alcoholic Fatty Liver Disease
mesh term: Liver Cirrhosis
mesh term: Cenicriviroc
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 