<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/NCT01717326</url>
  </required_header>
  <id_info>
    <org_study_id>5172-035</org_study_id>
    <secondary_id>2012-003354-89</secondary_id>
    <nct_id>NCT01717326</nct_id>
  </id_info>
  <brief_title>A Study of the Combination Regimen Grazoprevir (MK-5172) and Elbasvir (MK-8742) ± Ribavirin in Participants With Chronic Hepatitis C (MK-5172-035)</brief_title>
  <acronym>C-WORTHy</acronym>
  <official_title>A Phase II Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen MK-5172 and MK-8742 ± Ribavirin (RBV) in Subjects With Chronic Hepatitis C Virus Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Merck Sharp &amp; Dohme LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a study of the safety and efficacy of grazoprevir (MK-5172) in combination with&#xD;
      elbasvir (MK-8742) ± ribavirin (RBV). The primary efficacy endpoint will be Sustained&#xD;
      Virologic Response 12 weeks after the end of all study therapy (SVR12) in each of the&#xD;
      treatment arms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Part A is being done in treatment-naïve (TN), genotype 1 (GT1), interferon eligible,&#xD;
      non-cirrhotic (N-C) participants with chronic hepatitis C (CHC). Participants will be&#xD;
      assigned randomly to 1 of 2 treatment arms in which they will receive grazoprevir 100 mg once&#xD;
      daily (QD) + elbasvir 20 mg or 50 mg QD and twice daily (BID) RBV, or to a treatment arm in&#xD;
      which they will receive grazoprevir 100 mg QD + elbasvir 50 mg QD without RBV. Treatment will&#xD;
      last 12 weeks.&#xD;
&#xD;
      In Part B, participants with hepatitis C virus (HCV) GT1 and HCV ribonucleic acid (RNA)&#xD;
      levels of ≥10,000 IU/mL will be randomly assigned to a study arm, based on absence or&#xD;
      presence of cirrhosis (C), whether they are TN or had poor response to previous antiviral&#xD;
      therapy (null responders [NR]), or whether co-infected with human immunodeficiency virus&#xD;
      (HIV); these participants will receive open-label grazoprevir (100 mg) in combination with&#xD;
      elbasvir (50 mg) ± RBV. Treatment will last 8 to 18 weeks dependent on arm assignment.&#xD;
&#xD;
      In Part C, TN, N-C participants with HCV GT1b and HCV RNA levels of ≥10,000 IU/mL will be&#xD;
      randomly assigned to receive open-label grazoprevir (100 mg) in combination with elbasvir (50&#xD;
      mg) ± RBV. Treatment will last 8 weeks.&#xD;
&#xD;
      In Part D, TN N-C participants with HCV GT3 and HCV RNA levels of ≥10,000 IU/mL will be&#xD;
      randomly assigned to receive open-label grazoprevir (100 mg) in combination with elbasvir (50&#xD;
      mg) + RBV for 12 or 18 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 7, 2013</start_date>
  <completion_date type="Actual">May 6, 2015</completion_date>
  <primary_completion_date type="Actual">February 23, 2015</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12)</measure>
    <time_frame>12 weeks after end of therapy (up to 30 weeks)</time_frame>
    <description>Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). SVR12 was defined as HCV RNA &lt;25 IU/ml at 12 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Experiencing at Least One Adverse Event (AE) During the Treatment Period and First 14 Follow-up Days</measure>
    <time_frame>From Day 1 [post-dose] through 14 days following last dose of study drug (up to 20 weeks)</time_frame>
    <description>An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, was also an AE.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Discontinuing Study Therapy Due to an AE During the Treatment Period and First 14 Follow-up Days</measure>
    <time_frame>From Day 1 [post-dose] through 14 days following last dose of study drug (up to 20 weeks)</time_frame>
    <description>An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, was also an AE.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Time to First Achievement of Undetectable Hepatitis C Virus Ribonucleic Acid (HCV RNA)</measure>
    <time_frame>From first dose of study medication until first achievement of undetectable HCV RNA (up to 18 weeks of treatment)</time_frame>
    <description>Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. Kaplan Meier summary statistics were used to characterize the time to first achievement of undetectable HCV RNA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Undetectable HCV RNA at Week 2</measure>
    <time_frame>Week 2</time_frame>
    <description>HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. Undetectable HCV RNA was defined as below the 15.1 IU/ml limit of detection. The percentage of participants achieving undetectable HCV RNA and accompanying 95% CIs were reported at TW2 for each treatment arm of the PP Population. 95% confidence intervals provided based on the Clopper-Pearson method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Undetectable HCV RNA at Week 4</measure>
    <time_frame>Week 4</time_frame>
    <description>HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. Undetectable HCV RNA was defined as below the 15.1 IU/ml limit of detection. The percentage of participants achieving undetectable HCV RNA and accompanying 95% CIs were reported at TW4 for each treatment arm of the PP Population. 95% confidence intervals provided based on the Clopper-Pearson method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Undetectable HCV RNA at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. Undetectable HCV RNA was defined as below the 15.1 IU/ml limit of detection. The percentage of participants achieving undetectable HCV RNA and accompanying 95% CIs were reported at TW12 for each treatment arm of the PP Population (as applicable). 95% confidence intervals provided based on the Clopper-Pearson method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving HCV RNA &lt;25 IU/mL at Week 2</measure>
    <time_frame>Week 2</time_frame>
    <description>HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). The percentage of participants achieving HCV RNA levels &lt;25 IU/ml and accompanying 95% CIs were reported at TW2 for each treatment arm of the PP Population. 95% confidence intervals provided based on the Clopper-Pearson method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving HCV RNA &lt;25 IU/mL at Week 4</measure>
    <time_frame>Week 4</time_frame>
    <description>HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). The percentage of participants achieving HCV RNA levels &lt;25 IU/ml and accompanying 95% CIs were reported at TW4 for each treatment arm of the PP Population. 95% confidence intervals provided based on the Clopper-Pearson method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving HCV RNA &lt;25 IU/mL at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). The percentage of participants achieving HCV RNA levels &lt;25 IU/ml and accompanying 95% CIs were reported at TW12 for each treatment arm of the PP Population (as applicable). 95% confidence intervals provided based on the Clopper-Pearson method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Sustained Virologic Response 4 Weeks After the End of All Therapy (SVR4)</measure>
    <time_frame>4 weeks after end of therapy (up to 22 weeks)</time_frame>
    <description>Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). SVR4 was defined as HCV RNA &lt;25 IU/ml at 4 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of All Study Therapy (SVR24)</measure>
    <time_frame>24 weeks after end of therapy (up to 42 weeks)</time_frame>
    <description>Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). SVR24 was defined as HCV RNA &lt;25 IU/ml at 24 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method.</description>
  </secondary_outcome>
  <number_of_arms>20</number_of_arms>
  <enrollment type="Actual">573</enrollment>
  <condition>Hepatitis C</condition>
  <arm_group>
    <arm_group_label>A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight</description>
  </arm_group>
  <arm_group>
    <arm_group_label>A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight</description>
  </arm_group>
  <arm_group>
    <arm_group_label>A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-12 wk</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg-12 wk</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B7: TN C Grazoprevir 100 mg + Elbasvir 50 mg-18 wk</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B9: NR Grazoprevir 100 mg + Elbasvir 50 mg-12 wk</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B11: NR Grazoprevir 100 mg + Elbasvir 50 mg-18 wk</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg-12 wk</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-8 wk</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight</description>
  </arm_group>
  <arm_group>
    <arm_group_label>D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Grazoprevir</intervention_name>
    <description>100 mg tablet orally QD</description>
    <arm_group_label>A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk</arm_group_label>
    <arm_group_label>A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</arm_group_label>
    <arm_group_label>A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-12 wk</arm_group_label>
    <arm_group_label>B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</arm_group_label>
    <arm_group_label>B11: NR Grazoprevir 100 mg + Elbasvir 50 mg-18 wk</arm_group_label>
    <arm_group_label>B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</arm_group_label>
    <arm_group_label>B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg-12 wk</arm_group_label>
    <arm_group_label>B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</arm_group_label>
    <arm_group_label>B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</arm_group_label>
    <arm_group_label>B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg-12 wk</arm_group_label>
    <arm_group_label>B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</arm_group_label>
    <arm_group_label>B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk</arm_group_label>
    <arm_group_label>B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk</arm_group_label>
    <arm_group_label>B7: TN C Grazoprevir 100 mg + Elbasvir 50 mg-18 wk</arm_group_label>
    <arm_group_label>B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk</arm_group_label>
    <arm_group_label>B9: NR Grazoprevir 100 mg + Elbasvir 50 mg-12 wk</arm_group_label>
    <arm_group_label>C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</arm_group_label>
    <arm_group_label>C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-8 wk</arm_group_label>
    <arm_group_label>D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</arm_group_label>
    <arm_group_label>D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk</arm_group_label>
    <other_name>MK-5172</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Elbasvir</intervention_name>
    <description>Part A: 20 or 50 mg capsule orally QD Parts B, C, and D: 50 mg capsule orally QD</description>
    <arm_group_label>A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk</arm_group_label>
    <arm_group_label>A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</arm_group_label>
    <arm_group_label>A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-12 wk</arm_group_label>
    <arm_group_label>B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</arm_group_label>
    <arm_group_label>B11: NR Grazoprevir 100 mg + Elbasvir 50 mg-18 wk</arm_group_label>
    <arm_group_label>B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</arm_group_label>
    <arm_group_label>B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg-12 wk</arm_group_label>
    <arm_group_label>B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</arm_group_label>
    <arm_group_label>B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</arm_group_label>
    <arm_group_label>B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg-12 wk</arm_group_label>
    <arm_group_label>B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</arm_group_label>
    <arm_group_label>B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk</arm_group_label>
    <arm_group_label>B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk</arm_group_label>
    <arm_group_label>B7: TN C Grazoprevir 100 mg + Elbasvir 50 mg-18 wk</arm_group_label>
    <arm_group_label>B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk</arm_group_label>
    <arm_group_label>B9: NR Grazoprevir 100 mg + Elbasvir 50 mg-12 wk</arm_group_label>
    <arm_group_label>C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</arm_group_label>
    <arm_group_label>C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-8 wk</arm_group_label>
    <arm_group_label>D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</arm_group_label>
    <arm_group_label>D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk</arm_group_label>
    <other_name>MK-8742</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo to Elbasvir</intervention_name>
    <description>Placebo to Elbasvir 20 or 50 mg capsule, orally, once daily for 12 weeks to maintain blind (Part A only)</description>
    <arm_group_label>A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk</arm_group_label>
    <arm_group_label>A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ribavirin</intervention_name>
    <description>Oral capsules BID at a total daily dose from 800 to 1400 mg based on participant weight</description>
    <arm_group_label>A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk</arm_group_label>
    <arm_group_label>A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</arm_group_label>
    <arm_group_label>B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</arm_group_label>
    <arm_group_label>B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</arm_group_label>
    <arm_group_label>B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</arm_group_label>
    <arm_group_label>B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</arm_group_label>
    <arm_group_label>B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</arm_group_label>
    <arm_group_label>B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk</arm_group_label>
    <arm_group_label>B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk</arm_group_label>
    <arm_group_label>C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</arm_group_label>
    <arm_group_label>D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</arm_group_label>
    <arm_group_label>D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk</arm_group_label>
    <other_name>Rebetol™</other_name>
    <other_name>RBV</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        All participants&#xD;
&#xD;
          -  CHC genotype 1 (GT1) virus infection (Parts A, B, and C) or GT3 virus infection (Part&#xD;
             D)&#xD;
&#xD;
          -  Female participants of childbearing potential or male participant with female partners&#xD;
             of childbearing potential, must use two acceptable methods of birth control from ≥2&#xD;
             weeks prior to Day 1 until ≥6 months after last dose of study drug, or longer if&#xD;
             dictated by local regulations&#xD;
&#xD;
        Part A - Absence (no medical history or physical findings) of ascites, bleeding esophageal&#xD;
        varices, hepatic encephalopathy, or other signs or symptoms of advanced liver disease, or&#xD;
        cirrhosis - No evidence of advanced fibrosis, cirrhosis and/or hepatocellular carcinoma by&#xD;
        biopsy or noninvasive testing (FibroScan and/or FibroTest)&#xD;
&#xD;
        Parts B, C, and D&#xD;
&#xD;
          -  Treatment naïve with or without cirrhosis, or&#xD;
&#xD;
          -  Prior treatment failure to Peg-IFN/Ribavirin with or without cirrhosis, or&#xD;
&#xD;
          -  Co-infected with human immunodeficiency virus (HIV) without cirrhosis&#xD;
&#xD;
          -  Absence (no medical history or physical findings) of ascites, bleeding esophageal&#xD;
             varices, hepatic encephalopathy, or other signs or symptoms of advanced liver disease&#xD;
&#xD;
          -  Liver disease staging assessment by liver biopsy or noninvasive testing (FibroScan&#xD;
             and/or FibroTest)&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        All participants&#xD;
&#xD;
          -  Non-GT1 HCV infection (Part A, Part B, and Part C) or a non-GT3 HCV infection (Part D)&#xD;
             including a mixed GT infection (with a non-GT1 [Part A, Part B, and Part C] or non-GT3&#xD;
             [Part D]) or a non-typeable genotype&#xD;
&#xD;
          -  Evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC&#xD;
&#xD;
          -  Currently participating or participated in a study with an investigational compound&#xD;
             within 30 days of signing informed consent and is not willing to refrain from&#xD;
             participating in another study&#xD;
&#xD;
          -  Diabetic and/or hypertensive with clinically significant ocular examination findings&#xD;
&#xD;
          -  History of depression associated with hospitalization for depression,&#xD;
             electroconvulsive therapy, or resulting in prolonged absence from work and/or&#xD;
             significant disruption of daily functions&#xD;
&#xD;
          -  Suicidal or homicidal ideations and/or attempt, or history of severe psychiatric&#xD;
             disorders&#xD;
&#xD;
          -  Clinical diagnosis of substance abuse&#xD;
&#xD;
          -  Current history of seizure disorder, stroke, or transient ischemic attack&#xD;
&#xD;
          -  Immunologically mediated disease&#xD;
&#xD;
          -  Chronic pulmonary disease&#xD;
&#xD;
          -  Clinically significant cardiac abnormalities/dysfunction&#xD;
&#xD;
          -  Active clinical gout within the last year&#xD;
&#xD;
          -  Hemoglobinopathy or myelodysplastic syndromes&#xD;
&#xD;
          -  History of organ transplants including hematopoietic stem cell transplants&#xD;
&#xD;
          -  Poor venous access&#xD;
&#xD;
          -  Indwelling venous catheter&#xD;
&#xD;
          -  History of gastric surgery or malabsorption disorders&#xD;
&#xD;
          -  Severe concurrent disease&#xD;
&#xD;
          -  Evidence of active or suspected malignancy, or a history of malignancy, ≤5 years&#xD;
             before&#xD;
&#xD;
          -  Pregnant, lactating, expecting to conceive or donate eggs&#xD;
&#xD;
          -  Male participant with pregnant female partner&#xD;
&#xD;
          -  Member/family member of the investigational study or sponsor staff directly involved&#xD;
             with this study&#xD;
&#xD;
          -  Evidence or history of chronic hepatitis not caused by HCV&#xD;
&#xD;
        Part A&#xD;
&#xD;
          -  Not treatment-naïve&#xD;
&#xD;
          -  Documented to be HIV positive&#xD;
&#xD;
          -  Taking or planning to take significant inducers or inhibitors of CYP3A4 substrates or&#xD;
             herbal supplements 2 weeks prior to start of study medications&#xD;
&#xD;
        Parts B, C, and D&#xD;
&#xD;
          -  Previously received any HCV direct-acting antivirals&#xD;
&#xD;
          -  Requiring, or likely to require, chronic systemic administration of corticosteroids&#xD;
             during the course of the trial&#xD;
&#xD;
          -  For participants diagnosed with diabetes mellitus, documented HbA1c &gt;8.5%&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <removed_countries>
    <country>Denmark</country>
    <country>France</country>
    <country>United States</country>
  </removed_countries>
  <reference>
    <citation>Lawitz E, Gane E, Pearlman B, Tam E, Ghesquiere W, Guyader D, Alric L, Bronowicki JP, Lester L, Sievert W, Ghalib R, Balart L, Sund F, Lagging M, Dutko F, Shaughnessy M, Hwang P, Howe AY, Wahl J, Robertson M, Barr E, Haber B. Efficacy and safety of 12 weeks versus 18 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin for hepatitis C virus genotype 1 infection in previously untreated patients with cirrhosis and patients with previous null response with or without cirrhosis (C-WORTHY): a randomised, open-label phase 2 trial. Lancet. 2015 Mar 21;385(9973):1075-86. doi: 10.1016/S0140-6736(14)61795-5. Epub 2014 Nov 11. Erratum In: Lancet. 2015 Mar 21;385(9973):1074.</citation>
    <PMID>25467591</PMID>
  </reference>
  <reference>
    <citation>Sulkowski M, Hezode C, Gerstoft J, Vierling JM, Mallolas J, Pol S, Kugelmas M, Murillo A, Weis N, Nahass R, Shibolet O, Serfaty L, Bourliere M, DeJesus E, Zuckerman E, Dutko F, Shaughnessy M, Hwang P, Howe AY, Wahl J, Robertson M, Barr E, Haber B. Efficacy and safety of 8 weeks versus 12 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin in patients with hepatitis C virus genotype 1 mono-infection and HIV/hepatitis C virus co-infection (C-WORTHY): a randomised, open-label phase 2 trial. Lancet. 2015 Mar 21;385(9973):1087-97. doi: 10.1016/S0140-6736(14)61793-1. Epub 2014 Nov 11.</citation>
    <PMID>25467560</PMID>
  </reference>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>October 26, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <results_first_submitted>February 16, 2016</results_first_submitted>
  <results_first_submitted_qc>April 21, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">May 30, 2016</results_first_posted>
  <last_update_submitted>January 15, 2021</last_update_submitted>
  <last_update_submitted_qc>January 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2021</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>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Hepatitis C, Chronic</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ribavirin</mesh_term>
    <mesh_term>Grazoprevir</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf</ipd_description>
    <ipd_url>http://engagezone.msd.com/ds_documentation.php</ipd_url>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Male/female participants with Hepatitis C Virus (HCV) genotype 1 (GT1) or GT3 who were either treatment-naïve (TN) or prior null responder (NR), cirrhotic (C) or noncirrhotic (NC), and monoinfected with HCV or coinfected with HCV and human immunodeficiency virus (HIV) were recruited based on entry requirements for Parts A, B, C, or D.</recruitment_details>
      <pre_assignment_details>573 participants were randomized on study. 65 TN NC GT1 participants were randomized in Part A. Part B randomized 94 TN NC participants, 123 TN C participants, 130 NR participants (C and NC), and 59 TN HIV coinfected participants. Part C randomized 61 TN NC GT1b participants, and Part D randomized 41 TN NC GT3 participants.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk</title>
          <description>GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
        </group>
        <group group_id="P2">
          <title>A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
          <description>GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
        </group>
        <group group_id="P3">
          <title>A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
          <description>GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
        </group>
        <group group_id="P4">
          <title>B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</title>
          <description>GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
        </group>
        <group group_id="P5">
          <title>B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
          <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
        </group>
        <group group_id="P6">
          <title>B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
          <description>GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
        </group>
        <group group_id="P7">
          <title>B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
          <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
        </group>
        <group group_id="P8">
          <title>B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk</title>
          <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
        </group>
        <group group_id="P9">
          <title>B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk</title>
          <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
        </group>
        <group group_id="P10">
          <title>B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk</title>
          <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.</description>
        </group>
        <group group_id="P11">
          <title>B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk</title>
          <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
        </group>
        <group group_id="P12">
          <title>B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
          <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
        </group>
        <group group_id="P13">
          <title>B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</title>
          <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
        </group>
        <group group_id="P14">
          <title>B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk</title>
          <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.</description>
        </group>
        <group group_id="P15">
          <title>B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
          <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
        </group>
        <group group_id="P16">
          <title>B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
          <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
        </group>
        <group group_id="P17">
          <title>C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</title>
          <description>GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
        </group>
        <group group_id="P18">
          <title>C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk</title>
          <description>GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.</description>
        </group>
        <group group_id="P19">
          <title>D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
          <description>GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
        </group>
        <group group_id="P20">
          <title>D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk</title>
          <description>GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="27"/>
                <participants group_id="P3" count="13"/>
                <participants group_id="P4" count="30"/>
                <participants group_id="P5" count="33"/>
                <participants group_id="P6" count="31"/>
                <participants group_id="P7" count="31"/>
                <participants group_id="P8" count="29"/>
                <participants group_id="P9" count="32"/>
                <participants group_id="P10" count="31"/>
                <participants group_id="P11" count="32"/>
                <participants group_id="P12" count="33"/>
                <participants group_id="P13" count="33"/>
                <participants group_id="P14" count="32"/>
                <participants group_id="P15" count="29"/>
                <participants group_id="P16" count="30"/>
                <participants group_id="P17" count="30"/>
                <participants group_id="P18" count="31"/>
                <participants group_id="P19" count="20"/>
                <participants group_id="P20" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="28">Number includes 1 additional participant randomized to A3 but treated on A2</participants>
                <participants group_id="P3" count="12">Number excludes 1 participant randomized to A3 but treated on Arm A2</participants>
                <participants group_id="P4" count="30"/>
                <participants group_id="P5" count="33"/>
                <participants group_id="P6" count="31"/>
                <participants group_id="P7" count="31"/>
                <participants group_id="P8" count="29"/>
                <participants group_id="P9" count="32"/>
                <participants group_id="P10" count="31"/>
                <participants group_id="P11" count="32"/>
                <participants group_id="P12" count="33"/>
                <participants group_id="P13" count="33"/>
                <participants group_id="P14" count="32"/>
                <participants group_id="P15" count="29"/>
                <participants group_id="P16" count="30"/>
                <participants group_id="P17" count="30"/>
                <participants group_id="P18" count="31"/>
                <participants group_id="P19" count="20"/>
                <participants group_id="P20" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="26"/>
                <participants group_id="P3" count="13"/>
                <participants group_id="P4" count="28"/>
                <participants group_id="P5" count="31"/>
                <participants group_id="P6" count="31"/>
                <participants group_id="P7" count="30"/>
                <participants group_id="P8" count="29"/>
                <participants group_id="P9" count="32"/>
                <participants group_id="P10" count="29"/>
                <participants group_id="P11" count="30"/>
                <participants group_id="P12" count="33"/>
                <participants group_id="P13" count="32"/>
                <participants group_id="P14" count="32"/>
                <participants group_id="P15" count="29"/>
                <participants group_id="P16" count="27"/>
                <participants group_id="P17" count="29"/>
                <participants group_id="P18" count="31"/>
                <participants group_id="P19" count="16"/>
                <participants group_id="P20" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="2"/>
                <participants group_id="P11" count="2"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="1"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="3"/>
                <participants group_id="P17" count="1"/>
                <participants group_id="P18" count="0"/>
                <participants group_id="P19" count="4"/>
                <participants group_id="P20" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="1"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
                <participants group_id="P18" count="0"/>
                <participants group_id="P19" count="0"/>
                <participants group_id="P20" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="1"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="2"/>
                <participants group_id="P17" count="1"/>
                <participants group_id="P18" count="0"/>
                <participants group_id="P19" count="2"/>
                <participants group_id="P20" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="1"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
                <participants group_id="P18" count="0"/>
                <participants group_id="P19" count="0"/>
                <participants group_id="P20" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
                <participants group_id="P18" count="0"/>
                <participants group_id="P19" count="0"/>
                <participants group_id="P20" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="1"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="1"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="1"/>
                <participants group_id="P17" count="0"/>
                <participants group_id="P18" count="0"/>
                <participants group_id="P19" count="2"/>
                <participants group_id="P20" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Full Analysis Set (FAS); all randomized participants who received ≥1 dose of study treatment.</population>
      <group_list>
        <group group_id="B1">
          <title>A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk</title>
          <description>GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
        </group>
        <group group_id="B2">
          <title>A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
          <description>GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
        </group>
        <group group_id="B3">
          <title>A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
          <description>GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
        </group>
        <group group_id="B4">
          <title>B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</title>
          <description>GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
        </group>
        <group group_id="B5">
          <title>B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
          <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
        </group>
        <group group_id="B6">
          <title>B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
          <description>GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
        </group>
        <group group_id="B7">
          <title>B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
          <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
        </group>
        <group group_id="B8">
          <title>B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk</title>
          <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
        </group>
        <group group_id="B9">
          <title>B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk</title>
          <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
        </group>
        <group group_id="B10">
          <title>B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk</title>
          <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.</description>
        </group>
        <group group_id="B11">
          <title>B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk</title>
          <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
        </group>
        <group group_id="B12">
          <title>B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
          <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
        </group>
        <group group_id="B13">
          <title>B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</title>
          <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
        </group>
        <group group_id="B14">
          <title>B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk</title>
          <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.</description>
        </group>
        <group group_id="B15">
          <title>B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
          <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
        </group>
        <group group_id="B16">
          <title>B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
          <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
        </group>
        <group group_id="B17">
          <title>C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</title>
          <description>GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
        </group>
        <group group_id="B18">
          <title>C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk</title>
          <description>GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.</description>
        </group>
        <group group_id="B19">
          <title>D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
          <description>GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
        </group>
        <group group_id="B20">
          <title>D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk</title>
          <description>GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
        </group>
        <group group_id="B21">
          <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="25"/>
            <count group_id="B2" value="27"/>
            <count group_id="B3" value="13"/>
            <count group_id="B4" value="30"/>
            <count group_id="B5" value="33"/>
            <count group_id="B6" value="31"/>
            <count group_id="B7" value="31"/>
            <count group_id="B8" value="29"/>
            <count group_id="B9" value="32"/>
            <count group_id="B10" value="31"/>
            <count group_id="B11" value="32"/>
            <count group_id="B12" value="33"/>
            <count group_id="B13" value="33"/>
            <count group_id="B14" value="32"/>
            <count group_id="B15" value="29"/>
            <count group_id="B16" value="30"/>
            <count group_id="B17" value="30"/>
            <count group_id="B18" value="31"/>
            <count group_id="B19" value="20"/>
            <count group_id="B20" value="21"/>
            <count group_id="B21" value="573"/>
          </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="48.7" spread="12.5"/>
                    <measurement group_id="B2" value="43.9" spread="12.6"/>
                    <measurement group_id="B3" value="43.3" spread="13.5"/>
                    <measurement group_id="B4" value="48.4" spread="11.9"/>
                    <measurement group_id="B5" value="49.7" spread="11.5"/>
                    <measurement group_id="B6" value="53.6" spread="8.4"/>
                    <measurement group_id="B7" value="57.0" spread="7.0"/>
                    <measurement group_id="B8" value="59.0" spread="7.8"/>
                    <measurement group_id="B9" value="58.8" spread="8.2"/>
                    <measurement group_id="B10" value="58.9" spread="8.0"/>
                    <measurement group_id="B11" value="52.2" spread="8.8"/>
                    <measurement group_id="B12" value="54.4" spread="9.1"/>
                    <measurement group_id="B13" value="56.2" spread="10.9"/>
                    <measurement group_id="B14" value="54.3" spread="12.3"/>
                    <measurement group_id="B15" value="46.2" spread="8.4"/>
                    <measurement group_id="B16" value="43.5" spread="10.4"/>
                    <measurement group_id="B17" value="50.6" spread="10.9"/>
                    <measurement group_id="B18" value="55.3" spread="10.3"/>
                    <measurement group_id="B19" value="49.0" spread="11.5"/>
                    <measurement group_id="B20" value="42.4" spread="10.8"/>
                    <measurement group_id="B21" value="51.9" spread="11.3"/>
                  </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="13"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="12"/>
                    <measurement group_id="B5" value="15"/>
                    <measurement group_id="B6" value="15"/>
                    <measurement group_id="B7" value="12"/>
                    <measurement group_id="B8" value="10"/>
                    <measurement group_id="B9" value="17"/>
                    <measurement group_id="B10" value="10"/>
                    <measurement group_id="B11" value="12"/>
                    <measurement group_id="B12" value="13"/>
                    <measurement group_id="B13" value="17"/>
                    <measurement group_id="B14" value="14"/>
                    <measurement group_id="B15" value="6"/>
                    <measurement group_id="B16" value="6"/>
                    <measurement group_id="B17" value="14"/>
                    <measurement group_id="B18" value="18"/>
                    <measurement group_id="B19" value="12"/>
                    <measurement group_id="B20" value="13"/>
                    <measurement group_id="B21" value="252"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="18"/>
                    <measurement group_id="B5" value="18"/>
                    <measurement group_id="B6" value="16"/>
                    <measurement group_id="B7" value="19"/>
                    <measurement group_id="B8" value="19"/>
                    <measurement group_id="B9" value="15"/>
                    <measurement group_id="B10" value="21"/>
                    <measurement group_id="B11" value="20"/>
                    <measurement group_id="B12" value="20"/>
                    <measurement group_id="B13" value="16"/>
                    <measurement group_id="B14" value="18"/>
                    <measurement group_id="B15" value="23"/>
                    <measurement group_id="B16" value="24"/>
                    <measurement group_id="B17" value="16"/>
                    <measurement group_id="B18" value="13"/>
                    <measurement group_id="B19" value="8"/>
                    <measurement group_id="B20" value="8"/>
                    <measurement group_id="B21" value="321"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12)</title>
        <description>Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). SVR12 was defined as HCV RNA &lt;25 IU/ml at 12 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method.</description>
        <time_frame>12 weeks after end of therapy (up to 30 weeks)</time_frame>
        <population>The Per-Protocol (PP) population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point.</population>
        <group_list>
          <group group_id="O1">
            <title>A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk</title>
            <description>GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O2">
            <title>A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O3">
            <title>A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
            <description>GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</title>
            <description>GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O5">
            <title>B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O6">
            <title>B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
            <description>GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O7">
            <title>B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O8">
            <title>B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O9">
            <title>B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O10">
            <title>B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.</description>
          </group>
          <group group_id="O11">
            <title>B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O12">
            <title>B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O13">
            <title>B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O14">
            <title>B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.</description>
          </group>
          <group group_id="O15">
            <title>B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O16">
            <title>B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O17">
            <title>C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</title>
            <description>GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O18">
            <title>C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk</title>
            <description>GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.</description>
          </group>
          <group group_id="O19">
            <title>D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O20">
            <title>D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk</title>
            <description>GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12)</title>
          <description>Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). SVR12 was defined as HCV RNA &lt;25 IU/ml at 12 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method.</description>
          <population>The Per-Protocol (PP) population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point.</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="22"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="29"/>
                <count group_id="O5" value="29"/>
                <count group_id="O6" value="31"/>
                <count group_id="O7" value="30"/>
                <count group_id="O8" value="29"/>
                <count group_id="O9" value="31"/>
                <count group_id="O10" value="31"/>
                <count group_id="O11" value="30"/>
                <count group_id="O12" value="33"/>
                <count group_id="O13" value="33"/>
                <count group_id="O14" value="32"/>
                <count group_id="O15" value="29"/>
                <count group_id="O16" value="28"/>
                <count group_id="O17" value="29"/>
                <count group_id="O18" value="31"/>
                <count group_id="O19" value="19"/>
                <count group_id="O20" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="84.6" upper_limit="100.0"/>
                    <measurement group_id="O2" value="95.8" lower_limit="78.9" upper_limit="99.9"/>
                    <measurement group_id="O3" value="100.0" lower_limit="73.5" upper_limit="100.0"/>
                    <measurement group_id="O4" value="82.8" lower_limit="64.2" upper_limit="94.2"/>
                    <measurement group_id="O5" value="100.0" lower_limit="88.1" upper_limit="100.0"/>
                    <measurement group_id="O6" value="96.8" lower_limit="83.3" upper_limit="99.9"/>
                    <measurement group_id="O7" value="90.0" lower_limit="73.5" upper_limit="97.9"/>
                    <measurement group_id="O8" value="96.6" lower_limit="82.2" upper_limit="99.9"/>
                    <measurement group_id="O9" value="100.0" lower_limit="88.8" upper_limit="100.0"/>
                    <measurement group_id="O10" value="93.5" lower_limit="78.6" upper_limit="99.2"/>
                    <measurement group_id="O11" value="100.0" lower_limit="88.4" upper_limit="100.0"/>
                    <measurement group_id="O12" value="90.9" lower_limit="75.7" upper_limit="98.1"/>
                    <measurement group_id="O13" value="100.0" lower_limit="89.4" upper_limit="100.0"/>
                    <measurement group_id="O14" value="96.9" lower_limit="83.8" upper_limit="99.9"/>
                    <measurement group_id="O15" value="96.6" lower_limit="82.2" upper_limit="99.9"/>
                    <measurement group_id="O16" value="92.9" lower_limit="76.5" upper_limit="99.1"/>
                    <measurement group_id="O17" value="93.1" lower_limit="77.2" upper_limit="99.2"/>
                    <measurement group_id="O18" value="93.5" lower_limit="78.6" upper_limit="99.2"/>
                    <measurement group_id="O19" value="47.4" lower_limit="24.4" upper_limit="71.1"/>
                    <measurement group_id="O20" value="61.1" lower_limit="35.7" upper_limit="82.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Experiencing at Least One Adverse Event (AE) During the Treatment Period and First 14 Follow-up Days</title>
        <description>An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, was also an AE.</description>
        <time_frame>From Day 1 [post-dose] through 14 days following last dose of study drug (up to 20 weeks)</time_frame>
        <population>All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).</population>
        <group_list>
          <group group_id="O1">
            <title>A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk</title>
            <description>GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O2">
            <title>A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O3">
            <title>A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
            <description>GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</title>
            <description>GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O5">
            <title>B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O6">
            <title>B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
            <description>GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O7">
            <title>B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O8">
            <title>B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O9">
            <title>B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O10">
            <title>B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.</description>
          </group>
          <group group_id="O11">
            <title>B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O12">
            <title>B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O13">
            <title>B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O14">
            <title>B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.</description>
          </group>
          <group group_id="O15">
            <title>B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O16">
            <title>B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O17">
            <title>C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</title>
            <description>GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O18">
            <title>C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk</title>
            <description>GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.</description>
          </group>
          <group group_id="O19">
            <title>D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O20">
            <title>D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk</title>
            <description>GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Experiencing at Least One Adverse Event (AE) During the Treatment Period and First 14 Follow-up Days</title>
          <description>An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, was also an AE.</description>
          <population>All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).</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="25"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="30"/>
                <count group_id="O5" value="33"/>
                <count group_id="O6" value="31"/>
                <count group_id="O7" value="31"/>
                <count group_id="O8" value="29"/>
                <count group_id="O9" value="32"/>
                <count group_id="O10" value="31"/>
                <count group_id="O11" value="32"/>
                <count group_id="O12" value="33"/>
                <count group_id="O13" value="33"/>
                <count group_id="O14" value="32"/>
                <count group_id="O15" value="29"/>
                <count group_id="O16" value="30"/>
                <count group_id="O17" value="30"/>
                <count group_id="O18" value="31"/>
                <count group_id="O19" value="20"/>
                <count group_id="O20" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.0" lower_limit="68.8" upper_limit="97.5"/>
                    <measurement group_id="O2" value="85.7" lower_limit="67.3" upper_limit="96.0"/>
                    <measurement group_id="O3" value="91.7" lower_limit="61.5" upper_limit="99.8"/>
                    <measurement group_id="O4" value="90.0" lower_limit="73.5" upper_limit="97.9"/>
                    <measurement group_id="O5" value="72.7" lower_limit="54.5" upper_limit="86.7"/>
                    <measurement group_id="O6" value="87.1" lower_limit="70.2" upper_limit="96.4"/>
                    <measurement group_id="O7" value="77.4" lower_limit="58.9" upper_limit="90.4"/>
                    <measurement group_id="O8" value="65.5" lower_limit="45.7" upper_limit="82.1"/>
                    <measurement group_id="O9" value="87.5" lower_limit="71.0" upper_limit="96.5"/>
                    <measurement group_id="O10" value="83.9" lower_limit="66.3" upper_limit="94.5"/>
                    <measurement group_id="O11" value="81.3" lower_limit="63.6" upper_limit="92.8"/>
                    <measurement group_id="O12" value="78.8" lower_limit="61.1" upper_limit="91.0"/>
                    <measurement group_id="O13" value="97.0" lower_limit="84.2" upper_limit="99.9"/>
                    <measurement group_id="O14" value="81.3" lower_limit="63.6" upper_limit="92.8"/>
                    <measurement group_id="O15" value="65.5" lower_limit="45.7" upper_limit="82.1"/>
                    <measurement group_id="O16" value="53.3" lower_limit="34.3" upper_limit="71.7"/>
                    <measurement group_id="O17" value="73.3" lower_limit="54.1" upper_limit="87.7"/>
                    <measurement group_id="O18" value="54.8" lower_limit="36.0" upper_limit="72.7"/>
                    <measurement group_id="O19" value="85.0" lower_limit="62.1" upper_limit="96.8"/>
                    <measurement group_id="O20" value="90.5" lower_limit="69.6" upper_limit="98.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Discontinuing Study Therapy Due to an AE During the Treatment Period and First 14 Follow-up Days</title>
        <description>An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, was also an AE.</description>
        <time_frame>From Day 1 [post-dose] through 14 days following last dose of study drug (up to 20 weeks)</time_frame>
        <population>APaT population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).</population>
        <group_list>
          <group group_id="O1">
            <title>A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk</title>
            <description>GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O2">
            <title>A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O3">
            <title>A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
            <description>GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</title>
            <description>GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O5">
            <title>B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O6">
            <title>B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
            <description>GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O7">
            <title>B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O8">
            <title>B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O9">
            <title>B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O10">
            <title>B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.</description>
          </group>
          <group group_id="O11">
            <title>B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O12">
            <title>B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O13">
            <title>B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O14">
            <title>B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.</description>
          </group>
          <group group_id="O15">
            <title>B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O16">
            <title>B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O17">
            <title>C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</title>
            <description>GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O18">
            <title>C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk</title>
            <description>GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.</description>
          </group>
          <group group_id="O19">
            <title>D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O20">
            <title>D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk</title>
            <description>GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Discontinuing Study Therapy Due to an AE During the Treatment Period and First 14 Follow-up Days</title>
          <description>An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, was also an AE.</description>
          <population>APaT population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).</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="25"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="30"/>
                <count group_id="O5" value="33"/>
                <count group_id="O6" value="31"/>
                <count group_id="O7" value="31"/>
                <count group_id="O8" value="29"/>
                <count group_id="O9" value="32"/>
                <count group_id="O10" value="31"/>
                <count group_id="O11" value="32"/>
                <count group_id="O12" value="33"/>
                <count group_id="O13" value="33"/>
                <count group_id="O14" value="32"/>
                <count group_id="O15" value="29"/>
                <count group_id="O16" value="30"/>
                <count group_id="O17" value="30"/>
                <count group_id="O18" value="31"/>
                <count group_id="O19" value="20"/>
                <count group_id="O20" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="13.7"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="12.3"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="26.5"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="11.6"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="10.6"/>
                    <measurement group_id="O6" value="0.0" lower_limit="0.0" upper_limit="11.2"/>
                    <measurement group_id="O7" value="0.0" lower_limit="0.0" upper_limit="11.2"/>
                    <measurement group_id="O8" value="0.0" lower_limit="0.0" upper_limit="11.9"/>
                    <measurement group_id="O9" value="6.3" lower_limit="0.8" upper_limit="20.8"/>
                    <measurement group_id="O10" value="0.0" lower_limit="0.0" upper_limit="11.2"/>
                    <measurement group_id="O11" value="3.1" lower_limit="0.1" upper_limit="16.2"/>
                    <measurement group_id="O12" value="0.0" lower_limit="0.0" upper_limit="10.6"/>
                    <measurement group_id="O13" value="0.0" lower_limit="0.0" upper_limit="10.6"/>
                    <measurement group_id="O14" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O15" value="0.0" lower_limit="0.0" upper_limit="11.9"/>
                    <measurement group_id="O16" value="0.0" lower_limit="0.0" upper_limit="11.6"/>
                    <measurement group_id="O17" value="0.0" lower_limit="0.0" upper_limit="11.6"/>
                    <measurement group_id="O18" value="0.0" lower_limit="0.0" upper_limit="11.2"/>
                    <measurement group_id="O19" value="0.0" lower_limit="0.0" upper_limit="16.8"/>
                    <measurement group_id="O20" value="4.8" lower_limit="0.1" upper_limit="23.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Time to First Achievement of Undetectable Hepatitis C Virus Ribonucleic Acid (HCV RNA)</title>
        <description>Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. Kaplan Meier summary statistics were used to characterize the time to first achievement of undetectable HCV RNA.</description>
        <time_frame>From first dose of study medication until first achievement of undetectable HCV RNA (up to 18 weeks of treatment)</time_frame>
        <population>FAS; all randomized participants who received ≥1 dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk</title>
            <description>GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O2">
            <title>A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O3">
            <title>A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
            <description>GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</title>
            <description>GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O5">
            <title>B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O6">
            <title>B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
            <description>GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O7">
            <title>B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O8">
            <title>B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O9">
            <title>B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O10">
            <title>B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.</description>
          </group>
          <group group_id="O11">
            <title>B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O12">
            <title>B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O13">
            <title>B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O14">
            <title>B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.</description>
          </group>
          <group group_id="O15">
            <title>B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O16">
            <title>B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O17">
            <title>C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</title>
            <description>GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O18">
            <title>C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk</title>
            <description>GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.</description>
          </group>
          <group group_id="O19">
            <title>D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O20">
            <title>D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk</title>
            <description>GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Time to First Achievement of Undetectable Hepatitis C Virus Ribonucleic Acid (HCV RNA)</title>
          <description>Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. Kaplan Meier summary statistics were used to characterize the time to first achievement of undetectable HCV RNA.</description>
          <population>FAS; all randomized participants who received ≥1 dose of study treatment.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="27"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="30"/>
                <count group_id="O5" value="33"/>
                <count group_id="O6" value="31"/>
                <count group_id="O7" value="31"/>
                <count group_id="O8" value="29"/>
                <count group_id="O9" value="32"/>
                <count group_id="O10" value="31"/>
                <count group_id="O11" value="32"/>
                <count group_id="O12" value="33"/>
                <count group_id="O13" value="33"/>
                <count group_id="O14" value="32"/>
                <count group_id="O15" value="29"/>
                <count group_id="O16" value="30"/>
                <count group_id="O17" value="30"/>
                <count group_id="O18" value="31"/>
                <count group_id="O19" value="20"/>
                <count group_id="O20" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.7" spread="2.2"/>
                    <measurement group_id="O2" value="19.2" spread="1.8"/>
                    <measurement group_id="O3" value="23.4" spread="2.9"/>
                    <measurement group_id="O4" value="27.9" spread="3.0"/>
                    <measurement group_id="O5" value="30.7" spread="2.3"/>
                    <measurement group_id="O6" value="32.0" spread="3.0"/>
                    <measurement group_id="O7" value="37.0" spread="2.8"/>
                    <measurement group_id="O8" value="33.2" spread="2.4"/>
                    <measurement group_id="O9" value="33.1" spread="2.8"/>
                    <measurement group_id="O10" value="33.7" spread="2.6"/>
                    <measurement group_id="O11" value="31.9" spread="2.2"/>
                    <measurement group_id="O12" value="37.4" spread="2.5"/>
                    <measurement group_id="O13" value="37.4" spread="2.7"/>
                    <measurement group_id="O14" value="42.7" spread="3.3"/>
                    <measurement group_id="O15" value="27.6" spread="3.0"/>
                    <measurement group_id="O16" value="29.0" spread="2.9"/>
                    <measurement group_id="O17" value="23.7" spread="2.1"/>
                    <measurement group_id="O18" value="34.5" spread="2.6"/>
                    <measurement group_id="O19" value="30.1" spread="3.7"/>
                    <measurement group_id="O20" value="19.8" spread="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving Undetectable HCV RNA at Week 2</title>
        <description>HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. Undetectable HCV RNA was defined as below the 15.1 IU/ml limit of detection. The percentage of participants achieving undetectable HCV RNA and accompanying 95% CIs were reported at TW2 for each treatment arm of the PP Population. 95% confidence intervals provided based on the Clopper-Pearson method.</description>
        <time_frame>Week 2</time_frame>
        <population>The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point.</population>
        <group_list>
          <group group_id="O1">
            <title>A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk</title>
            <description>GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O2">
            <title>A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O3">
            <title>A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
            <description>GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</title>
            <description>GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O5">
            <title>B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O6">
            <title>B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
            <description>GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O7">
            <title>B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O8">
            <title>B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O9">
            <title>B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O10">
            <title>B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.</description>
          </group>
          <group group_id="O11">
            <title>B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O12">
            <title>B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O13">
            <title>B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O14">
            <title>B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.</description>
          </group>
          <group group_id="O15">
            <title>B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O16">
            <title>B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O17">
            <title>C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</title>
            <description>GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O18">
            <title>C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk</title>
            <description>GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.</description>
          </group>
          <group group_id="O19">
            <title>D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O20">
            <title>D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk</title>
            <description>GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Undetectable HCV RNA at Week 2</title>
          <description>HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. Undetectable HCV RNA was defined as below the 15.1 IU/ml limit of detection. The percentage of participants achieving undetectable HCV RNA and accompanying 95% CIs were reported at TW2 for each treatment arm of the PP Population. 95% confidence intervals provided based on the Clopper-Pearson method.</description>
          <population>The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point.</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="23"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="29"/>
                <count group_id="O5" value="30"/>
                <count group_id="O6" value="31"/>
                <count group_id="O7" value="30"/>
                <count group_id="O8" value="29"/>
                <count group_id="O9" value="32"/>
                <count group_id="O10" value="31"/>
                <count group_id="O11" value="31"/>
                <count group_id="O12" value="33"/>
                <count group_id="O13" value="33"/>
                <count group_id="O14" value="32"/>
                <count group_id="O15" value="29"/>
                <count group_id="O16" value="30"/>
                <count group_id="O17" value="30"/>
                <count group_id="O18" value="31"/>
                <count group_id="O19" value="20"/>
                <count group_id="O20" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.2" lower_limit="30.6" upper_limit="73.2"/>
                    <measurement group_id="O2" value="44.0" lower_limit="24.4" upper_limit="65.1"/>
                    <measurement group_id="O3" value="41.7" lower_limit="15.2" upper_limit="72.3"/>
                    <measurement group_id="O4" value="44.8" lower_limit="26.4" upper_limit="64.3"/>
                    <measurement group_id="O5" value="20.0" lower_limit="7.7" upper_limit="38.6"/>
                    <measurement group_id="O6" value="16.1" lower_limit="5.5" upper_limit="33.7"/>
                    <measurement group_id="O7" value="6.7" lower_limit="0.8" upper_limit="22.1"/>
                    <measurement group_id="O8" value="10.3" lower_limit="2.2" upper_limit="27.4"/>
                    <measurement group_id="O9" value="25.0" lower_limit="11.5" upper_limit="43.4"/>
                    <measurement group_id="O10" value="16.1" lower_limit="5.5" upper_limit="33.7"/>
                    <measurement group_id="O11" value="12.9" lower_limit="3.6" upper_limit="29.8"/>
                    <measurement group_id="O12" value="6.1" lower_limit="0.7" upper_limit="20.2"/>
                    <measurement group_id="O13" value="6.1" lower_limit="0.7" upper_limit="20.2"/>
                    <measurement group_id="O14" value="6.3" lower_limit="0.8" upper_limit="20.8"/>
                    <measurement group_id="O15" value="37.9" lower_limit="20.7" upper_limit="57.7"/>
                    <measurement group_id="O16" value="40.0" lower_limit="22.7" upper_limit="59.4"/>
                    <measurement group_id="O17" value="46.7" lower_limit="28.3" upper_limit="65.7"/>
                    <measurement group_id="O18" value="12.9" lower_limit="3.6" upper_limit="29.8"/>
                    <measurement group_id="O19" value="40.0" lower_limit="19.1" upper_limit="63.9"/>
                    <measurement group_id="O20" value="70.0" lower_limit="45.7" upper_limit="88.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving Undetectable HCV RNA at Week 4</title>
        <description>HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. Undetectable HCV RNA was defined as below the 15.1 IU/ml limit of detection. The percentage of participants achieving undetectable HCV RNA and accompanying 95% CIs were reported at TW4 for each treatment arm of the PP Population. 95% confidence intervals provided based on the Clopper-Pearson method.</description>
        <time_frame>Week 4</time_frame>
        <population>The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point.</population>
        <group_list>
          <group group_id="O1">
            <title>A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk</title>
            <description>GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O2">
            <title>A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O3">
            <title>A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
            <description>GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</title>
            <description>GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O5">
            <title>B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O6">
            <title>B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
            <description>GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O7">
            <title>B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O8">
            <title>B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O9">
            <title>B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O10">
            <title>B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.</description>
          </group>
          <group group_id="O11">
            <title>B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O12">
            <title>B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O13">
            <title>B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O14">
            <title>B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.</description>
          </group>
          <group group_id="O15">
            <title>B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O16">
            <title>B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O17">
            <title>C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</title>
            <description>GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O18">
            <title>C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk</title>
            <description>GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.</description>
          </group>
          <group group_id="O19">
            <title>D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O20">
            <title>D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk</title>
            <description>GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Undetectable HCV RNA at Week 4</title>
          <description>HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. Undetectable HCV RNA was defined as below the 15.1 IU/ml limit of detection. The percentage of participants achieving undetectable HCV RNA and accompanying 95% CIs were reported at TW4 for each treatment arm of the PP Population. 95% confidence intervals provided based on the Clopper-Pearson method.</description>
          <population>The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point.</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="23"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="30"/>
                <count group_id="O5" value="30"/>
                <count group_id="O6" value="31"/>
                <count group_id="O7" value="30"/>
                <count group_id="O8" value="29"/>
                <count group_id="O9" value="32"/>
                <count group_id="O10" value="31"/>
                <count group_id="O11" value="30"/>
                <count group_id="O12" value="32"/>
                <count group_id="O13" value="33"/>
                <count group_id="O14" value="32"/>
                <count group_id="O15" value="29"/>
                <count group_id="O16" value="28"/>
                <count group_id="O17" value="30"/>
                <count group_id="O18" value="31"/>
                <count group_id="O19" value="20"/>
                <count group_id="O20" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.9" lower_limit="51.6" upper_limit="89.8"/>
                    <measurement group_id="O2" value="91.7" lower_limit="73.0" upper_limit="99.0"/>
                    <measurement group_id="O3" value="75.0" lower_limit="42.8" upper_limit="94.5"/>
                    <measurement group_id="O4" value="73.3" lower_limit="54.1" upper_limit="87.7"/>
                    <measurement group_id="O5" value="83.3" lower_limit="65.3" upper_limit="94.4"/>
                    <measurement group_id="O6" value="77.4" lower_limit="58.9" upper_limit="90.4"/>
                    <measurement group_id="O7" value="60.0" lower_limit="40.6" upper_limit="77.3"/>
                    <measurement group_id="O8" value="79.3" lower_limit="60.3" upper_limit="92.0"/>
                    <measurement group_id="O9" value="71.9" lower_limit="53.3" upper_limit="86.3"/>
                    <measurement group_id="O10" value="71.0" lower_limit="52.0" upper_limit="85.8"/>
                    <measurement group_id="O11" value="83.3" lower_limit="65.3" upper_limit="94.4"/>
                    <measurement group_id="O12" value="68.8" lower_limit="50.0" upper_limit="83.9"/>
                    <measurement group_id="O13" value="69.7" lower_limit="51.3" upper_limit="84.4"/>
                    <measurement group_id="O14" value="53.1" lower_limit="34.7" upper_limit="70.9"/>
                    <measurement group_id="O15" value="75.9" lower_limit="56.5" upper_limit="89.7"/>
                    <measurement group_id="O16" value="78.6" lower_limit="59.0" upper_limit="91.7"/>
                    <measurement group_id="O17" value="86.7" lower_limit="69.3" upper_limit="96.2"/>
                    <measurement group_id="O18" value="74.2" lower_limit="55.4" upper_limit="88.1"/>
                    <measurement group_id="O19" value="50.0" lower_limit="27.2" upper_limit="72.8"/>
                    <measurement group_id="O20" value="77.8" lower_limit="52.4" upper_limit="93.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving Undetectable HCV RNA at Week 12</title>
        <description>HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. Undetectable HCV RNA was defined as below the 15.1 IU/ml limit of detection. The percentage of participants achieving undetectable HCV RNA and accompanying 95% CIs were reported at TW12 for each treatment arm of the PP Population (as applicable). 95% confidence intervals provided based on the Clopper-Pearson method.</description>
        <time_frame>Week 12</time_frame>
        <population>The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point. The B1, C1, and C2 arms only received 8 weeks of treatment and were thus excluded from this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk</title>
            <description>GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O2">
            <title>A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O3">
            <title>A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
            <description>GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</title>
            <description>GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O5">
            <title>B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O6">
            <title>B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
            <description>GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O7">
            <title>B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O8">
            <title>B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O9">
            <title>B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O10">
            <title>B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.</description>
          </group>
          <group group_id="O11">
            <title>B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O12">
            <title>B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O13">
            <title>B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O14">
            <title>B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.</description>
          </group>
          <group group_id="O15">
            <title>B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O16">
            <title>B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O17">
            <title>C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</title>
            <description>GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O18">
            <title>C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk</title>
            <description>GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.</description>
          </group>
          <group group_id="O19">
            <title>D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O20">
            <title>D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk</title>
            <description>GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Undetectable HCV RNA at Week 12</title>
          <description>HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. Undetectable HCV RNA was defined as below the 15.1 IU/ml limit of detection. The percentage of participants achieving undetectable HCV RNA and accompanying 95% CIs were reported at TW12 for each treatment arm of the PP Population (as applicable). 95% confidence intervals provided based on the Clopper-Pearson method.</description>
          <population>The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point. The B1, C1, and C2 arms only received 8 weeks of treatment and were thus excluded from this analysis.</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="22"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="29"/>
                <count group_id="O6" value="31"/>
                <count group_id="O7" value="30"/>
                <count group_id="O8" value="29"/>
                <count group_id="O9" value="31"/>
                <count group_id="O10" value="31"/>
                <count group_id="O11" value="30"/>
                <count group_id="O12" value="32"/>
                <count group_id="O13" value="33"/>
                <count group_id="O14" value="32"/>
                <count group_id="O15" value="29"/>
                <count group_id="O16" value="28"/>
                <count group_id="O17" value="0"/>
                <count group_id="O18" value="0"/>
                <count group_id="O19" value="19"/>
                <count group_id="O20" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="84.6" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100.0" lower_limit="85.8" upper_limit="100.0"/>
                    <measurement group_id="O3" value="100.0" lower_limit="73.5" upper_limit="100.0"/>
                    <measurement group_id="O5" value="100.0" lower_limit="88.1" upper_limit="100.0"/>
                    <measurement group_id="O6" value="100.0" lower_limit="88.8" upper_limit="100.0"/>
                    <measurement group_id="O7" value="93.3" lower_limit="77.9" upper_limit="99.2"/>
                    <measurement group_id="O8" value="96.6" lower_limit="82.2" upper_limit="99.9"/>
                    <measurement group_id="O9" value="100.0" lower_limit="88.8" upper_limit="100.0"/>
                    <measurement group_id="O10" value="100.0" lower_limit="88.8" upper_limit="100.0"/>
                    <measurement group_id="O11" value="100.0" lower_limit="88.4" upper_limit="100.0"/>
                    <measurement group_id="O12" value="93.8" lower_limit="79.2" upper_limit="99.2"/>
                    <measurement group_id="O13" value="100.0" lower_limit="89.4" upper_limit="100.0"/>
                    <measurement group_id="O14" value="96.9" lower_limit="83.8" upper_limit="99.9"/>
                    <measurement group_id="O15" value="93.1" lower_limit="77.2" upper_limit="99.2"/>
                    <measurement group_id="O16" value="92.9" lower_limit="76.5" upper_limit="99.1"/>
                    <measurement group_id="O19" value="47.7" lower_limit="24.4" upper_limit="71.1"/>
                    <measurement group_id="O20" value="65.0" lower_limit="40.8" upper_limit="84.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving HCV RNA &lt;25 IU/mL at Week 2</title>
        <description>HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). The percentage of participants achieving HCV RNA levels &lt;25 IU/ml and accompanying 95% CIs were reported at TW2 for each treatment arm of the PP Population. 95% confidence intervals provided based on the Clopper-Pearson method.</description>
        <time_frame>Week 2</time_frame>
        <population>The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point.</population>
        <group_list>
          <group group_id="O1">
            <title>A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk</title>
            <description>GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O2">
            <title>A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O3">
            <title>A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
            <description>GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</title>
            <description>GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O5">
            <title>B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O6">
            <title>B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
            <description>GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O7">
            <title>B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O8">
            <title>B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O9">
            <title>B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O10">
            <title>B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.</description>
          </group>
          <group group_id="O11">
            <title>B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O12">
            <title>B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O13">
            <title>B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O14">
            <title>B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.</description>
          </group>
          <group group_id="O15">
            <title>B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O16">
            <title>B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O17">
            <title>C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</title>
            <description>GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O18">
            <title>C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk</title>
            <description>GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.</description>
          </group>
          <group group_id="O19">
            <title>D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O20">
            <title>D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk</title>
            <description>GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving HCV RNA &lt;25 IU/mL at Week 2</title>
          <description>HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). The percentage of participants achieving HCV RNA levels &lt;25 IU/ml and accompanying 95% CIs were reported at TW2 for each treatment arm of the PP Population. 95% confidence intervals provided based on the Clopper-Pearson method.</description>
          <population>The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point.</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="23"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="29"/>
                <count group_id="O5" value="30"/>
                <count group_id="O6" value="31"/>
                <count group_id="O7" value="30"/>
                <count group_id="O8" value="29"/>
                <count group_id="O9" value="32"/>
                <count group_id="O10" value="31"/>
                <count group_id="O11" value="31"/>
                <count group_id="O12" value="33"/>
                <count group_id="O13" value="33"/>
                <count group_id="O14" value="32"/>
                <count group_id="O15" value="29"/>
                <count group_id="O16" value="30"/>
                <count group_id="O17" value="30"/>
                <count group_id="O18" value="31"/>
                <count group_id="O19" value="20"/>
                <count group_id="O20" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.3" lower_limit="72.0" upper_limit="98.9"/>
                    <measurement group_id="O2" value="92.0" lower_limit="74.0" upper_limit="99.0"/>
                    <measurement group_id="O3" value="91.7" lower_limit="61.5" upper_limit="99.8"/>
                    <measurement group_id="O4" value="86.2" lower_limit="68.3" upper_limit="96.1"/>
                    <measurement group_id="O5" value="73.3" lower_limit="54.1" upper_limit="87.7"/>
                    <measurement group_id="O6" value="77.4" lower_limit="58.9" upper_limit="90.4"/>
                    <measurement group_id="O7" value="60.0" lower_limit="40.6" upper_limit="77.3"/>
                    <measurement group_id="O8" value="79.3" lower_limit="60.3" upper_limit="92.0"/>
                    <measurement group_id="O9" value="78.1" lower_limit="60.0" upper_limit="90.7"/>
                    <measurement group_id="O10" value="67.7" lower_limit="48.6" upper_limit="83.3"/>
                    <measurement group_id="O11" value="77.4" lower_limit="58.9" upper_limit="90.4"/>
                    <measurement group_id="O12" value="66.7" lower_limit="48.2" upper_limit="82.0"/>
                    <measurement group_id="O13" value="57.6" lower_limit="39.2" upper_limit="74.5"/>
                    <measurement group_id="O14" value="62.5" lower_limit="43.7" upper_limit="78.9"/>
                    <measurement group_id="O15" value="89.7" lower_limit="72.6" upper_limit="97.8"/>
                    <measurement group_id="O16" value="76.7" lower_limit="57.7" upper_limit="90.1"/>
                    <measurement group_id="O17" value="76.7" lower_limit="57.7" upper_limit="90.1"/>
                    <measurement group_id="O18" value="61.3" lower_limit="42.2" upper_limit="78.2"/>
                    <measurement group_id="O19" value="70.0" lower_limit="45.7" upper_limit="88.1"/>
                    <measurement group_id="O20" value="85.0" lower_limit="62.1" upper_limit="96.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving HCV RNA &lt;25 IU/mL at Week 4</title>
        <description>HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). The percentage of participants achieving HCV RNA levels &lt;25 IU/ml and accompanying 95% CIs were reported at TW4 for each treatment arm of the PP Population. 95% confidence intervals provided based on the Clopper-Pearson method.</description>
        <time_frame>Week 4</time_frame>
        <population>The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point.</population>
        <group_list>
          <group group_id="O1">
            <title>A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk</title>
            <description>GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O2">
            <title>A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O3">
            <title>A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
            <description>GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</title>
            <description>GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O5">
            <title>B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O6">
            <title>B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
            <description>GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O7">
            <title>B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O8">
            <title>B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O9">
            <title>B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O10">
            <title>B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.</description>
          </group>
          <group group_id="O11">
            <title>B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O12">
            <title>B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O13">
            <title>B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O14">
            <title>B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.</description>
          </group>
          <group group_id="O15">
            <title>B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O16">
            <title>B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O17">
            <title>C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</title>
            <description>GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O18">
            <title>C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk</title>
            <description>GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.</description>
          </group>
          <group group_id="O19">
            <title>D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O20">
            <title>D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk</title>
            <description>GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving HCV RNA &lt;25 IU/mL at Week 4</title>
          <description>HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). The percentage of participants achieving HCV RNA levels &lt;25 IU/ml and accompanying 95% CIs were reported at TW4 for each treatment arm of the PP Population. 95% confidence intervals provided based on the Clopper-Pearson method.</description>
          <population>The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point.</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="23"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="30"/>
                <count group_id="O5" value="30"/>
                <count group_id="O6" value="31"/>
                <count group_id="O7" value="30"/>
                <count group_id="O8" value="29"/>
                <count group_id="O9" value="32"/>
                <count group_id="O10" value="31"/>
                <count group_id="O11" value="30"/>
                <count group_id="O12" value="32"/>
                <count group_id="O13" value="33"/>
                <count group_id="O14" value="32"/>
                <count group_id="O15" value="29"/>
                <count group_id="O16" value="28"/>
                <count group_id="O17" value="30"/>
                <count group_id="O18" value="31"/>
                <count group_id="O19" value="20"/>
                <count group_id="O20" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="85.2" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100.0" lower_limit="85.8" upper_limit="100.0"/>
                    <measurement group_id="O3" value="100.0" lower_limit="73.5" upper_limit="100.0"/>
                    <measurement group_id="O4" value="100.0" lower_limit="88.4" upper_limit="100.0"/>
                    <measurement group_id="O5" value="100.0" lower_limit="88.4" upper_limit="100.0"/>
                    <measurement group_id="O6" value="100.0" lower_limit="88.8" upper_limit="100.0"/>
                    <measurement group_id="O7" value="90.0" lower_limit="73.5" upper_limit="97.9"/>
                    <measurement group_id="O8" value="100.0" lower_limit="88.1" upper_limit="100.0"/>
                    <measurement group_id="O9" value="100.0" lower_limit="89.1" upper_limit="100.0"/>
                    <measurement group_id="O10" value="90.3" lower_limit="74.2" upper_limit="98.0"/>
                    <measurement group_id="O11" value="100.0" lower_limit="88.4" upper_limit="100.0"/>
                    <measurement group_id="O12" value="96.9" lower_limit="83.8" upper_limit="99.9"/>
                    <measurement group_id="O13" value="97.0" lower_limit="84.2" upper_limit="99.9"/>
                    <measurement group_id="O14" value="93.8" lower_limit="79.2" upper_limit="99.2"/>
                    <measurement group_id="O15" value="100.0" lower_limit="88.1" upper_limit="100.0"/>
                    <measurement group_id="O16" value="100.0" lower_limit="87.7" upper_limit="100.0"/>
                    <measurement group_id="O17" value="100.0" lower_limit="88.4" upper_limit="100.0"/>
                    <measurement group_id="O18" value="96.8" lower_limit="83.3" upper_limit="99.9"/>
                    <measurement group_id="O19" value="65.0" lower_limit="40.8" upper_limit="84.6"/>
                    <measurement group_id="O20" value="83.3" lower_limit="58.6" upper_limit="96.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving HCV RNA &lt;25 IU/mL at Week 12</title>
        <description>HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). The percentage of participants achieving HCV RNA levels &lt;25 IU/ml and accompanying 95% CIs were reported at TW12 for each treatment arm of the PP Population (as applicable). 95% confidence intervals provided based on the Clopper-Pearson method.</description>
        <time_frame>Week 12</time_frame>
        <population>The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point. The B1, C1, and C2 arms only received 8 weeks of treatment and were thus excluded from this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk</title>
            <description>GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O2">
            <title>A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O3">
            <title>A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
            <description>GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</title>
            <description>GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O5">
            <title>B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O6">
            <title>B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
            <description>GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O7">
            <title>B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O8">
            <title>B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O9">
            <title>B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O10">
            <title>B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.</description>
          </group>
          <group group_id="O11">
            <title>B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O12">
            <title>B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O13">
            <title>B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O14">
            <title>B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.</description>
          </group>
          <group group_id="O15">
            <title>B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O16">
            <title>B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O17">
            <title>C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</title>
            <description>GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O18">
            <title>C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk</title>
            <description>GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.</description>
          </group>
          <group group_id="O19">
            <title>D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O20">
            <title>D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk</title>
            <description>GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving HCV RNA &lt;25 IU/mL at Week 12</title>
          <description>HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). The percentage of participants achieving HCV RNA levels &lt;25 IU/ml and accompanying 95% CIs were reported at TW12 for each treatment arm of the PP Population (as applicable). 95% confidence intervals provided based on the Clopper-Pearson method.</description>
          <population>The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point. The B1, C1, and C2 arms only received 8 weeks of treatment and were thus excluded from this analysis.</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="22"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="29"/>
                <count group_id="O6" value="31"/>
                <count group_id="O7" value="30"/>
                <count group_id="O8" value="29"/>
                <count group_id="O9" value="31"/>
                <count group_id="O10" value="31"/>
                <count group_id="O11" value="30"/>
                <count group_id="O12" value="32"/>
                <count group_id="O13" value="33"/>
                <count group_id="O14" value="32"/>
                <count group_id="O15" value="29"/>
                <count group_id="O16" value="28"/>
                <count group_id="O17" value="0"/>
                <count group_id="O18" value="0"/>
                <count group_id="O19" value="19"/>
                <count group_id="O20" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="84.6" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100.0" lower_limit="85.8" upper_limit="100.0"/>
                    <measurement group_id="O3" value="100.0" lower_limit="73.5" upper_limit="100.0"/>
                    <measurement group_id="O5" value="100.0" lower_limit="88.1" upper_limit="100.0"/>
                    <measurement group_id="O6" value="100.0" lower_limit="88.8" upper_limit="100.0"/>
                    <measurement group_id="O7" value="93.3" lower_limit="77.9" upper_limit="99.2"/>
                    <measurement group_id="O8" value="100.0" lower_limit="88.1" upper_limit="100.0"/>
                    <measurement group_id="O9" value="100.0" lower_limit="88.8" upper_limit="100.0"/>
                    <measurement group_id="O10" value="100.0" lower_limit="88.8" upper_limit="100.0"/>
                    <measurement group_id="O11" value="100.0" lower_limit="88.4" upper_limit="100.0"/>
                    <measurement group_id="O12" value="100.0" lower_limit="89.1" upper_limit="100.0"/>
                    <measurement group_id="O13" value="100.0" lower_limit="89.4" upper_limit="100.0"/>
                    <measurement group_id="O14" value="96.9" lower_limit="83.8" upper_limit="99.9"/>
                    <measurement group_id="O15" value="100.0" lower_limit="88.1" upper_limit="100.0"/>
                    <measurement group_id="O16" value="92.9" lower_limit="76.5" upper_limit="99.1"/>
                    <measurement group_id="O19" value="47.4" lower_limit="24.4" upper_limit="71.1"/>
                    <measurement group_id="O20" value="75.0" lower_limit="50.9" upper_limit="91.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving Sustained Virologic Response 4 Weeks After the End of All Therapy (SVR4)</title>
        <description>Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). SVR4 was defined as HCV RNA &lt;25 IU/ml at 4 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method.</description>
        <time_frame>4 weeks after end of therapy (up to 22 weeks)</time_frame>
        <population>The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point.</population>
        <group_list>
          <group group_id="O1">
            <title>A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk</title>
            <description>GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O2">
            <title>A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O3">
            <title>A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
            <description>GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</title>
            <description>GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O5">
            <title>B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O6">
            <title>B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
            <description>GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O7">
            <title>B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O8">
            <title>B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O9">
            <title>B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O10">
            <title>B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.</description>
          </group>
          <group group_id="O11">
            <title>B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O12">
            <title>B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O13">
            <title>B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O14">
            <title>B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.</description>
          </group>
          <group group_id="O15">
            <title>B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O16">
            <title>B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O17">
            <title>C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</title>
            <description>GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O18">
            <title>C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk</title>
            <description>GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.</description>
          </group>
          <group group_id="O19">
            <title>D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O20">
            <title>D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk</title>
            <description>GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Sustained Virologic Response 4 Weeks After the End of All Therapy (SVR4)</title>
          <description>Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). SVR4 was defined as HCV RNA &lt;25 IU/ml at 4 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method.</description>
          <population>The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point.</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="22"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="30"/>
                <count group_id="O5" value="29"/>
                <count group_id="O6" value="31"/>
                <count group_id="O7" value="30"/>
                <count group_id="O8" value="29"/>
                <count group_id="O9" value="31"/>
                <count group_id="O10" value="31"/>
                <count group_id="O11" value="30"/>
                <count group_id="O12" value="33"/>
                <count group_id="O13" value="33"/>
                <count group_id="O14" value="32"/>
                <count group_id="O15" value="29"/>
                <count group_id="O16" value="29"/>
                <count group_id="O17" value="29"/>
                <count group_id="O18" value="31"/>
                <count group_id="O19" value="20"/>
                <count group_id="O20" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="84.6" upper_limit="100.0"/>
                    <measurement group_id="O2" value="95.8" lower_limit="78.9" upper_limit="99.9"/>
                    <measurement group_id="O3" value="100.0" lower_limit="73.5" upper_limit="100.0"/>
                    <measurement group_id="O4" value="93.3" lower_limit="77.9" upper_limit="99.2"/>
                    <measurement group_id="O5" value="100.0" lower_limit="88.1" upper_limit="100.0"/>
                    <measurement group_id="O6" value="96.8" lower_limit="83.3" upper_limit="99.9"/>
                    <measurement group_id="O7" value="96.7" lower_limit="82.8" upper_limit="99.9"/>
                    <measurement group_id="O8" value="96.6" lower_limit="82.2" upper_limit="99.9"/>
                    <measurement group_id="O9" value="100.0" lower_limit="88.8" upper_limit="100.0"/>
                    <measurement group_id="O10" value="96.8" lower_limit="83.3" upper_limit="99.9"/>
                    <measurement group_id="O11" value="100.0" lower_limit="88.4" upper_limit="100.0"/>
                    <measurement group_id="O12" value="93.9" lower_limit="79.8" upper_limit="99.3"/>
                    <measurement group_id="O13" value="100.0" lower_limit="89.4" upper_limit="100.0"/>
                    <measurement group_id="O14" value="96.9" lower_limit="83.8" upper_limit="99.9"/>
                    <measurement group_id="O15" value="96.6" lower_limit="82.2" upper_limit="99.9"/>
                    <measurement group_id="O16" value="93.1" lower_limit="77.2" upper_limit="99.2"/>
                    <measurement group_id="O17" value="93.1" lower_limit="77.2" upper_limit="99.2"/>
                    <measurement group_id="O18" value="96.8" lower_limit="83.3" upper_limit="99.9"/>
                    <measurement group_id="O19" value="50.0" lower_limit="27.2" upper_limit="72.8"/>
                    <measurement group_id="O20" value="61.1" lower_limit="35.7" upper_limit="82.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of All Study Therapy (SVR24)</title>
        <description>Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). SVR24 was defined as HCV RNA &lt;25 IU/ml at 24 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method.</description>
        <time_frame>24 weeks after end of therapy (up to 42 weeks)</time_frame>
        <population>The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point.</population>
        <group_list>
          <group group_id="O1">
            <title>A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk</title>
            <description>GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O2">
            <title>A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O3">
            <title>A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
            <description>GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</title>
            <description>GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O5">
            <title>B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O6">
            <title>B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
            <description>GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O7">
            <title>B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O8">
            <title>B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O9">
            <title>B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O10">
            <title>B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.</description>
          </group>
          <group group_id="O11">
            <title>B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O12">
            <title>B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O13">
            <title>B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O14">
            <title>B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.</description>
          </group>
          <group group_id="O15">
            <title>B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O16">
            <title>B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
            <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
          </group>
          <group group_id="O17">
            <title>C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</title>
            <description>GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O18">
            <title>C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk</title>
            <description>GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.</description>
          </group>
          <group group_id="O19">
            <title>D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
            <description>GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
          <group group_id="O20">
            <title>D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk</title>
            <description>GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of All Study Therapy (SVR24)</title>
          <description>Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). SVR24 was defined as HCV RNA &lt;25 IU/ml at 24 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method.</description>
          <population>The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point.</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="20"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="28"/>
                <count group_id="O5" value="29"/>
                <count group_id="O6" value="31"/>
                <count group_id="O7" value="30"/>
                <count group_id="O8" value="29"/>
                <count group_id="O9" value="31"/>
                <count group_id="O10" value="29"/>
                <count group_id="O11" value="29"/>
                <count group_id="O12" value="33"/>
                <count group_id="O13" value="32"/>
                <count group_id="O14" value="32"/>
                <count group_id="O15" value="29"/>
                <count group_id="O16" value="27"/>
                <count group_id="O17" value="29"/>
                <count group_id="O18" value="31"/>
                <count group_id="O19" value="19"/>
                <count group_id="O20" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="83.2" upper_limit="100.0"/>
                    <measurement group_id="O2" value="95.8" lower_limit="78.9" upper_limit="99.9"/>
                    <measurement group_id="O3" value="100.0" lower_limit="73.5" upper_limit="100.0"/>
                    <measurement group_id="O4" value="78.6" lower_limit="59.0" upper_limit="91.7"/>
                    <measurement group_id="O5" value="100.0" lower_limit="88.1" upper_limit="100.0"/>
                    <measurement group_id="O6" value="96.8" lower_limit="83.3" upper_limit="99.9"/>
                    <measurement group_id="O7" value="90.0" lower_limit="73.5" upper_limit="97.9"/>
                    <measurement group_id="O8" value="96.6" lower_limit="82.2" upper_limit="99.9"/>
                    <measurement group_id="O9" value="100.0" lower_limit="88.8" upper_limit="100.0"/>
                    <measurement group_id="O10" value="93.1" lower_limit="77.2" upper_limit="99.2"/>
                    <measurement group_id="O11" value="100.0" lower_limit="88.1" upper_limit="100.0"/>
                    <measurement group_id="O12" value="90.9" lower_limit="75.7" upper_limit="98.1"/>
                    <measurement group_id="O13" value="100.0" lower_limit="89.1" upper_limit="100.0"/>
                    <measurement group_id="O14" value="96.9" lower_limit="83.8" upper_limit="99.9"/>
                    <measurement group_id="O15" value="96.6" lower_limit="82.2" upper_limit="99.9"/>
                    <measurement group_id="O16" value="88.9" lower_limit="70.8" upper_limit="97.6"/>
                    <measurement group_id="O17" value="93.1" lower_limit="77.2" upper_limit="99.2"/>
                    <measurement group_id="O18" value="93.5" lower_limit="78.6" upper_limit="99.2"/>
                    <measurement group_id="O19" value="47.4" lower_limit="24.4" upper_limit="71.1"/>
                    <measurement group_id="O20" value="58.8" lower_limit="32.9" upper_limit="81.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Treatment and Follow-up periods (up to 42 weeks)</time_frame>
      <desc>All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).</desc>
      <group_list>
        <group group_id="E1">
          <title>A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk</title>
          <description>GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
        </group>
        <group group_id="E2">
          <title>A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
          <description>GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
        </group>
        <group group_id="E3">
          <title>A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
          <description>GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
        </group>
        <group group_id="E4">
          <title>B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</title>
          <description>GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
        </group>
        <group group_id="E5">
          <title>B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
          <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
        </group>
        <group group_id="E6">
          <title>B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
          <description>GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
        </group>
        <group group_id="E7">
          <title>B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
          <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
        </group>
        <group group_id="E8">
          <title>B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk</title>
          <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
        </group>
        <group group_id="E9">
          <title>B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk</title>
          <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
        </group>
        <group group_id="E10">
          <title>B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk</title>
          <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.</description>
        </group>
        <group group_id="E11">
          <title>B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk</title>
          <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
        </group>
        <group group_id="E12">
          <title>B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
          <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
        </group>
        <group group_id="E13">
          <title>B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</title>
          <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
        </group>
        <group group_id="E14">
          <title>B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk</title>
          <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.</description>
        </group>
        <group group_id="E15">
          <title>B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
          <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
        </group>
        <group group_id="E16">
          <title>B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk</title>
          <description>GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.</description>
        </group>
        <group group_id="E17">
          <title>C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk</title>
          <description>GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
        </group>
        <group group_id="E18">
          <title>C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk</title>
          <description>GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.</description>
        </group>
        <group group_id="E19">
          <title>D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk</title>
          <description>GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
        </group>
        <group group_id="E20">
          <title>D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk</title>
          <description>GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 18.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E16" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" subjects_affected="2" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E14" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholangitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Scrotal abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Staphylococcal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Hepatic cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Transitional cell carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Hydronephrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 18.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="28"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="27" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="23" subjects_at_risk="33"/>
                <counts group_id="E6" subjects_affected="24" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="23" subjects_at_risk="31"/>
                <counts group_id="E8" subjects_affected="18" subjects_at_risk="29"/>
                <counts group_id="E9" subjects_affected="26" subjects_at_risk="32"/>
                <counts group_id="E10" subjects_affected="24" subjects_at_risk="31"/>
                <counts group_id="E11" subjects_affected="24" subjects_at_risk="32"/>
                <counts group_id="E12" subjects_affected="25" subjects_at_risk="33"/>
                <counts group_id="E13" subjects_affected="32" subjects_at_risk="33"/>
                <counts group_id="E14" subjects_affected="25" subjects_at_risk="32"/>
                <counts group_id="E15" subjects_affected="18" subjects_at_risk="29"/>
                <counts group_id="E16" subjects_affected="14" subjects_at_risk="30"/>
                <counts group_id="E17" subjects_affected="22" subjects_at_risk="30"/>
                <counts group_id="E18" subjects_affected="14" subjects_at_risk="31"/>
                <counts group_id="E19" subjects_affected="16" subjects_at_risk="20"/>
                <counts group_id="E20" subjects_affected="20" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="25"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="4" subjects_affected="4" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="5" subjects_affected="5" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="3" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E14" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E20" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E10" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E14" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E15" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E13" events="4" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E14" events="3" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E15" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E20" events="3" subjects_affected="3" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="25"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="3" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="3" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E12" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E13" events="4" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E14" events="5" subjects_affected="5" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E20" events="2" subjects_affected="2" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E12" events="4" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E13" events="5" subjects_affected="4" subjects_at_risk="33"/>
                <counts group_id="E14" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="25"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="28"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="30"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E6" events="5" subjects_affected="4" subjects_at_risk="31"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E9" events="4" subjects_affected="4" subjects_at_risk="32"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="3" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E14" events="7" subjects_affected="7" subjects_at_risk="32"/>
                <counts group_id="E15" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E18" events="3" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E19" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E14" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E15" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E20" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="25"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E13" events="3" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E14" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="3" subjects_affected="3" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E13" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E14" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E15" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Frequent bowel movements</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E14" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E14" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E20" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="25"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="28"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E4" events="8" subjects_affected="8" subjects_at_risk="30"/>
                <counts group_id="E5" events="6" subjects_affected="6" subjects_at_risk="33"/>
                <counts group_id="E6" events="5" subjects_affected="5" subjects_at_risk="31"/>
                <counts group_id="E7" events="4" subjects_affected="4" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="5" subjects_affected="4" subjects_at_risk="32"/>
                <counts group_id="E10" events="5" subjects_affected="4" subjects_at_risk="31"/>
                <counts group_id="E11" events="4" subjects_affected="4" subjects_at_risk="32"/>
                <counts group_id="E12" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E13" events="6" subjects_affected="5" subjects_at_risk="33"/>
                <counts group_id="E14" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E17" events="6" subjects_affected="6" subjects_at_risk="30"/>
                <counts group_id="E18" events="3" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E19" events="3" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E20" events="7" subjects_affected="6" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Tooth impacted</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E9" events="5" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E10" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E12" events="3" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E13" events="3" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="3" subjects_affected="3" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E9" events="6" subjects_affected="5" subjects_at_risk="32"/>
                <counts group_id="E10" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E11" events="7" subjects_affected="7" subjects_at_risk="32"/>
                <counts group_id="E12" events="7" subjects_affected="5" subjects_at_risk="33"/>
                <counts group_id="E13" events="6" subjects_affected="6" subjects_at_risk="33"/>
                <counts group_id="E14" events="7" subjects_affected="7" subjects_at_risk="32"/>
                <counts group_id="E15" events="5" subjects_affected="4" subjects_at_risk="29"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E18" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E19" events="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E20" events="3" subjects_affected="3" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="3" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E10" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E13" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="2" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="25"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="28"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="12"/>
                <counts group_id="E4" events="15" subjects_affected="15" subjects_at_risk="30"/>
                <counts group_id="E5" events="10" subjects_affected="10" subjects_at_risk="33"/>
                <counts group_id="E6" events="7" subjects_affected="6" subjects_at_risk="31"/>
                <counts group_id="E7" events="11" subjects_affected="11" subjects_at_risk="31"/>
                <counts group_id="E8" events="6" subjects_affected="6" subjects_at_risk="29"/>
                <counts group_id="E9" events="10" subjects_affected="9" subjects_at_risk="32"/>
                <counts group_id="E10" events="7" subjects_affected="6" subjects_at_risk="31"/>
                <counts group_id="E11" events="6" subjects_affected="6" subjects_at_risk="32"/>
                <counts group_id="E12" events="12" subjects_affected="10" subjects_at_risk="33"/>
                <counts group_id="E13" events="16" subjects_affected="15" subjects_at_risk="33"/>
                <counts group_id="E14" events="8" subjects_affected="8" subjects_at_risk="32"/>
                <counts group_id="E15" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E16" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E17" events="11" subjects_affected="11" subjects_at_risk="30"/>
                <counts group_id="E18" events="3" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E19" events="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E20" events="3" subjects_affected="3" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E14" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E15" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E14" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E14" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperbilirubinaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E10" events="2" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E13" events="4" subjects_affected="4" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E10" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E14" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E12" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="5" subjects_affected="4" subjects_at_risk="31"/>
                <counts group_id="E11" events="3" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E13" events="6" subjects_affected="5" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="2" subjects_affected="2" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E9" events="3" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="3" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E20" events="5" subjects_affected="5" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="3" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Accidental overdose</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E5" events="5" subjects_affected="4" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="6" subjects_affected="5" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="3" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="5" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="4" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E20" events="4" subjects_affected="2" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Arthropod sting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Amylase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E14" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E15" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E18" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>International normalised ratio increased</sub_title>
                <counts group_id="E1" events="8" subjects_affected="3" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="5" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E10" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E12" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E13" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E14" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E5" events="3" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E8" events="4" subjects_affected="3" subjects_at_risk="29"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E10" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E11" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="4" subjects_affected="4" subjects_at_risk="33"/>
                <counts group_id="E14" events="4" subjects_affected="4" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E18" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E9" events="4" subjects_affected="4" subjects_at_risk="32"/>
                <counts group_id="E10" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E11" events="4" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E14" events="5" subjects_affected="5" subjects_at_risk="32"/>
                <counts group_id="E15" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Joint swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E14" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E13" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E14" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E12" events="8" subjects_affected="6" subjects_at_risk="33"/>
                <counts group_id="E13" events="6" subjects_affected="6" subjects_at_risk="33"/>
                <counts group_id="E14" events="4" subjects_affected="4" subjects_at_risk="32"/>
                <counts group_id="E15" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E18" events="4" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Disturbance in attention</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E13" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="25"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E10" events="4" subjects_affected="4" subjects_at_risk="31"/>
                <counts group_id="E11" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E13" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E20" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="25"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="28"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="12"/>
                <counts group_id="E4" events="7" subjects_affected="7" subjects_at_risk="30"/>
                <counts group_id="E5" events="9" subjects_affected="7" subjects_at_risk="33"/>
                <counts group_id="E6" events="11" subjects_affected="10" subjects_at_risk="31"/>
                <counts group_id="E7" events="3" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E8" events="5" subjects_affected="4" subjects_at_risk="29"/>
                <counts group_id="E9" events="13" subjects_affected="11" subjects_at_risk="32"/>
                <counts group_id="E10" events="12" subjects_affected="10" subjects_at_risk="31"/>
                <counts group_id="E11" events="12" subjects_affected="10" subjects_at_risk="32"/>
                <counts group_id="E12" events="6" subjects_affected="6" subjects_at_risk="33"/>
                <counts group_id="E13" events="7" subjects_affected="6" subjects_at_risk="33"/>
                <counts group_id="E14" events="10" subjects_affected="10" subjects_at_risk="32"/>
                <counts group_id="E15" events="5" subjects_affected="4" subjects_at_risk="29"/>
                <counts group_id="E16" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E17" events="6" subjects_affected="6" subjects_at_risk="30"/>
                <counts group_id="E18" events="6" subjects_affected="5" subjects_at_risk="31"/>
                <counts group_id="E19" events="5" subjects_affected="5" subjects_at_risk="20"/>
                <counts group_id="E20" events="5" subjects_affected="5" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E12" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Affect lability</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="3" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E13" events="3" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E20" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E10" events="2" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E11" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="3" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="25"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E5" events="8" subjects_affected="7" subjects_at_risk="33"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E7" events="5" subjects_affected="5" subjects_at_risk="31"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E9" events="4" subjects_affected="4" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="3" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E12" events="3" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E13" events="6" subjects_affected="6" subjects_at_risk="33"/>
                <counts group_id="E14" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E15" events="3" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="3" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E20" events="3" subjects_affected="3" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E11" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E13" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E14" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E15" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Mood swings</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Nightmare</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Sleep disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E7" events="4" subjects_affected="4" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="4" subjects_affected="4" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Chromaturia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E9" events="6" subjects_affected="6" subjects_at_risk="32"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E11" events="5" subjects_affected="5" subjects_at_risk="32"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E13" events="6" subjects_affected="5" subjects_at_risk="33"/>
                <counts group_id="E14" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E15" events="3" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E20" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="25"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="5" subjects_affected="5" subjects_at_risk="32"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E12" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E13" events="7" subjects_affected="6" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="3" subjects_affected="3" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="3" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="3" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E13" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E14" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="2" subjects_affected="2" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="4" subjects_affected="4" subjects_at_risk="32"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="4" subjects_affected="4" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E17" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E18" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E14" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E20" events="3" subjects_affected="2" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="6" subjects_affected="6" subjects_at_risk="30"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E9" events="5" subjects_affected="5" subjects_at_risk="32"/>
                <counts group_id="E10" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E12" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E13" events="10" subjects_affected="10" subjects_at_risk="33"/>
                <counts group_id="E14" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E15" events="3" subjects_affected="3" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="4" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E20" events="3" subjects_affected="3" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="28"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="4" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E7" events="4" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="8" subjects_affected="7" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="4" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E12" events="3" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E13" events="3" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="3" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E18" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E19" events="6" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E20" events="2" subjects_affected="2" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Rash pruritic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E6" events="3" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E14" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E16" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E20" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Results Point of Contact* Name or Official Title Senior Vice President, Global Clinical Development</name_or_title>
      <organization>Merck Sharp &amp; Dohme Corp.</organization>
      <phone>1-800-672-6372</phone>
      <email>ClinicalTrialsDisclosure@merck.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/NCT01717326
org study id: 5172-035
secondary id: 2012-003354-89
nct id: NCT01717326
lead sponsor: 
has dmc: No
This is a study of the safety and efficacy of grazoprevir (MK-5172) in combination with
      elbasvir (MK-8742) ± ribavirin (RBV). The primary efficacy endpoint will be Sustained
      Virologic Response 12 weeks after the end of all study therapy (SVR12) in each of the
      treatment arms.
Part A is being done in treatment-naïve (TN), genotype 1 (GT1), interferon eligible,
      non-cirrhotic (N-C) participants with chronic hepatitis C (CHC). Participants will be
      assigned randomly to 1 of 2 treatment arms in which they will receive grazoprevir 100 mg once
      daily (QD) + elbasvir 20 mg or 50 mg QD and twice daily (BID) RBV, or to a treatment arm in
      which they will receive grazoprevir 100 mg QD + elbasvir 50 mg QD without RBV. Treatment will
      last 12 weeks.

      In Part B, participants with hepatitis C virus (HCV) GT1 and HCV ribonucleic acid (RNA)
      levels of ≥10,000 IU/mL will be randomly assigned to a study arm, based on absence or
      presence of cirrhosis (C), whether they are TN or had poor response to previous antiviral
      therapy (null responders [NR]), or whether co-infected with human immunodeficiency virus
      (HIV); these participants will receive open-label grazoprevir (100 mg) in combination with
      elbasvir (50 mg) ± RBV. Treatment will last 8 to 18 weeks dependent on arm assignment.

      In Part C, TN, N-C participants with HCV GT1b and HCV RNA levels of ≥10,000 IU/mL will be
      randomly assigned to receive open-label grazoprevir (100 mg) in combination with elbasvir (50
      mg) ± RBV. Treatment will last 8 weeks.

      In Part D, TN N-C participants with HCV GT3 and HCV RNA levels of ≥10,000 IU/mL will be
      randomly assigned to receive open-label grazoprevir (100 mg) in combination with elbasvir (50
      mg) + RBV for 12 or 18 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12)
time frame: 12 weeks after end of therapy (up to 30 weeks)
description: Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). SVR12 was defined as HCV RNA <25 IU/ml at 12 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method.
measure: Percentage of Participants Experiencing at Least One Adverse Event (AE) During the Treatment Period and First 14 Follow-up Days
time frame: From Day 1 [post-dose] through 14 days following last dose of study drug (up to 20 weeks)
description: An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, was also an AE.
measure: Percentage of Participants Discontinuing Study Therapy Due to an AE During the Treatment Period and First 14 Follow-up Days
time frame: From Day 1 [post-dose] through 14 days following last dose of study drug (up to 20 weeks)
description: An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, was also an AE.
measure: Mean Time to First Achievement of Undetectable Hepatitis C Virus Ribonucleic Acid (HCV RNA)
time frame: From first dose of study medication until first achievement of undetectable HCV RNA (up to 18 weeks of treatment)
description: Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. Kaplan Meier summary statistics were used to characterize the time to first achievement of undetectable HCV RNA.
measure: Percentage of Participants Achieving Undetectable HCV RNA at Week 2
time frame: Week 2
description: HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. Undetectable HCV RNA was defined as below the 15.1 IU/ml limit of detection. The percentage of participants achieving undetectable HCV RNA and accompanying 95% CIs were reported at TW2 for each treatment arm of the PP Population. 95% confidence intervals provided based on the Clopper-Pearson method.
measure: Percentage of Participants Achieving Undetectable HCV RNA at Week 4
time frame: Week 4
description: HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. Undetectable HCV RNA was defined as below the 15.1 IU/ml limit of detection. The percentage of participants achieving undetectable HCV RNA and accompanying 95% CIs were reported at TW4 for each treatment arm of the PP Population. 95% confidence intervals provided based on the Clopper-Pearson method.
measure: Percentage of Participants Achieving Undetectable HCV RNA at Week 12
time frame: Week 12
description: HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. Undetectable HCV RNA was defined as below the 15.1 IU/ml limit of detection. The percentage of participants achieving undetectable HCV RNA and accompanying 95% CIs were reported at TW12 for each treatment arm of the PP Population (as applicable). 95% confidence intervals provided based on the Clopper-Pearson method.
measure: Percentage of Participants Achieving HCV RNA <25 IU/mL at Week 2
time frame: Week 2
description: HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). The percentage of participants achieving HCV RNA levels <25 IU/ml and accompanying 95% CIs were reported at TW2 for each treatment arm of the PP Population. 95% confidence intervals provided based on the Clopper-Pearson method.
measure: Percentage of Participants Achieving HCV RNA <25 IU/mL at Week 4
time frame: Week 4
description: HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). The percentage of participants achieving HCV RNA levels <25 IU/ml and accompanying 95% CIs were reported at TW4 for each treatment arm of the PP Population. 95% confidence intervals provided based on the Clopper-Pearson method.
measure: Percentage of Participants Achieving HCV RNA <25 IU/mL at Week 12
time frame: Week 12
description: HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). The percentage of participants achieving HCV RNA levels <25 IU/ml and accompanying 95% CIs were reported at TW12 for each treatment arm of the PP Population (as applicable). 95% confidence intervals provided based on the Clopper-Pearson method.
measure: Percentage of Participants Achieving Sustained Virologic Response 4 Weeks After the End of All Therapy (SVR4)
time frame: 4 weeks after end of therapy (up to 22 weeks)
description: Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). SVR4 was defined as HCV RNA <25 IU/ml at 4 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method.
measure: Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of All Study Therapy (SVR24)
time frame: 24 weeks after end of therapy (up to 42 weeks)
description: Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). SVR24 was defined as HCV RNA <25 IU/ml at 24 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method.
arm group label: A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk
arm group type: Experimental
description: GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight
arm group label: A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk
arm group type: Experimental
description: GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight
arm group label: A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-12 wk
arm group type: Experimental
description: GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks
arm group label: B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk
arm group type: Experimental
description: GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight
arm group label: B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk
arm group type: Experimental
description: GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight
arm group label: B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg-12 wk
arm group type: Experimental
description: GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks
arm group label: B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk
arm group type: Experimental
description: GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant
arm group label: B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk
arm group type: Experimental
description: GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks
arm group label: B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk
arm group type: Experimental
description: GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight
arm group label: B7: TN C Grazoprevir 100 mg + Elbasvir 50 mg-18 wk
arm group type: Experimental
description: GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks
arm group label: B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk
arm group type: Experimental
description: GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight
arm group label: B9: NR Grazoprevir 100 mg + Elbasvir 50 mg-12 wk
arm group type: Experimental
description: GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks
arm group label: B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk
arm group type: Experimental
description: GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight
arm group label: B11: NR Grazoprevir 100 mg + Elbasvir 50 mg-18 wk
arm group type: Experimental
description: GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks
arm group label: B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk
arm group type: Experimental
description: GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight
arm group label: B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg-12 wk
arm group type: Experimental
description: GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks
arm group label: C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk
arm group type: Experimental
description: GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
arm group label: C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-8 wk
arm group type: Experimental
description: GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks
arm group label: D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk
arm group type: Experimental
description: GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight
arm group label: D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk
arm group type: Experimental
description: GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight
intervention type: Drug
intervention name: Grazoprevir
description: 100 mg tablet orally QD
arm group label: A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk
arm group label: A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk
arm group label: A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-12 wk
arm group label: B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk
arm group label: B11: NR Grazoprevir 100 mg + Elbasvir 50 mg-18 wk
arm group label: B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk
arm group label: B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg-12 wk
arm group label: B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk
arm group label: B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk
arm group label: B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg-12 wk
arm group label: B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk
arm group label: B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk
arm group label: B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk
arm group label: B7: TN C Grazoprevir 100 mg + Elbasvir 50 mg-18 wk
arm group label: B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk
arm group label: B9: NR Grazoprevir 100 mg + Elbasvir 50 mg-12 wk
arm group label: C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk
arm group label: C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-8 wk
arm group label: D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk
arm group label: D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk
other name: MK-5172
intervention type: Drug
intervention name: Elbasvir
description: Part A: 20 or 50 mg capsule orally QD Parts B, C, and D: 50 mg capsule orally QD
arm group label: A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk
arm group label: A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk
arm group label: A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-12 wk
arm group label: B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk
arm group label: B11: NR Grazoprevir 100 mg + Elbasvir 50 mg-18 wk
arm group label: B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk
arm group label: B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg-12 wk
arm group label: B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk
arm group label: B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk
arm group label: B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg-12 wk
arm group label: B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk
arm group label: B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk
arm group label: B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk
arm group label: B7: TN C Grazoprevir 100 mg + Elbasvir 50 mg-18 wk
arm group label: B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk
arm group label: B9: NR Grazoprevir 100 mg + Elbasvir 50 mg-12 wk
arm group label: C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk
arm group label: C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-8 wk
arm group label: D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk
arm group label: D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk
other name: MK-8742
intervention type: Drug
intervention name: Placebo to Elbasvir
description: Placebo to Elbasvir 20 or 50 mg capsule, orally, once daily for 12 weeks to maintain blind (Part A only)
arm group label: A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk
arm group label: A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk
intervention type: Drug
intervention name: Ribavirin
description: Oral capsules BID at a total daily dose from 800 to 1400 mg based on participant weight
arm group label: A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk
arm group label: A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk
arm group label: B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk
arm group label: B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk
arm group label: B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk
arm group label: B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk
arm group label: B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk
arm group label: B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk
arm group label: B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk
arm group label: C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk
arm group label: D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk
arm group label: D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk
other name: Rebetol™
other name: RBV
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
country: Denmark
country: France
country: United States
citation: Lawitz E, Gane E, Pearlman B, Tam E, Ghesquiere W, Guyader D, Alric L, Bronowicki JP, Lester L, Sievert W, Ghalib R, Balart L, Sund F, Lagging M, Dutko F, Shaughnessy M, Hwang P, Howe AY, Wahl J, Robertson M, Barr E, Haber B. Efficacy and safety of 12 weeks versus 18 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin for hepatitis C virus genotype 1 infection in previously untreated patients with cirrhosis and patients with previous null response with or without cirrhosis (C-WORTHY): a randomised, open-label phase 2 trial. Lancet. 2015 Mar 21;385(9973):1075-86. doi: 10.1016/S0140-6736(14)61795-5. Epub 2014 Nov 11. Erratum In: Lancet. 2015 Mar 21;385(9973):1074.
PMID: 25467591
citation: Sulkowski M, Hezode C, Gerstoft J, Vierling JM, Mallolas J, Pol S, Kugelmas M, Murillo A, Weis N, Nahass R, Shibolet O, Serfaty L, Bourliere M, DeJesus E, Zuckerman E, Dutko F, Shaughnessy M, Hwang P, Howe AY, Wahl J, Robertson M, Barr E, Haber B. Efficacy and safety of 8 weeks versus 12 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin in patients with hepatitis C virus genotype 1 mono-infection and HIV/hepatitis C virus co-infection (C-WORTHY): a randomised, open-label phase 2 trial. Lancet. 2015 Mar 21;385(9973):1087-97. doi: 10.1016/S0140-6736(14)61793-1. Epub 2014 Nov 11.
PMID: 25467560
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis C, Chronic
mesh term: Hepatitis
mesh term: Ribavirin
mesh term: Grazoprevir
sharing ipd: Yes
ipd description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
ipd url: http://engagezone.msd.com/ds_documentation.php
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 