<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/NCT02243293</url>
  </required_header>
  <id_info>
    <org_study_id>M14-868</org_study_id>
    <secondary_id>2014-002927-90</secondary_id>
    <nct_id>NCT02243293</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without RBV in Subjects With Chronic Hepatitis C Virus (HCV) Genotypes 2, 3, 4, 5 or 6 Infection</brief_title>
  <official_title>A Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without RBV in Subjects With Chronic Hepatitis C Virus (HCV) Genotypes 2, 3, 4, 5 or 6 Infection (SURVEYOR-II)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AbbVie</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AbbVie</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this phase 2/3, open-label, multipart, multicenter study was to evaluate the&#xD;
      efficacy, and safety of co-administration of ABT-493 and ABT-530 with and without ribavirin&#xD;
      (RBV) in chronic HCV genotype 2 (GT2-), genotype 3 (GT3-), genotype 4 (GT4), genotype 5&#xD;
      (GT5-), or genotype 6 (GT6-) infected participants with or without cirrhosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study consisted of four independent parts with treatment and post-treatment periods of&#xD;
      enrollment. Parts 1 and 2 were the supportive/ exploratory parts (phase 2) of the study and&#xD;
      part 3 and 4 were the confirmatory/ registrational parts (phase 3) of the study. In parts 1&#xD;
      and 2 of the study, ABT-493 and ABT-530 were co-administered as separate tablets. However, in&#xD;
      parts 3 and 4 of the study, the ABT-493/ABT-530 co-formulated tablets were administered.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 19, 2014</start_date>
  <completion_date type="Actual">February 23, 2017</completion_date>
  <primary_completion_date type="Actual">October 25, 2016</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)</measure>
    <time_frame>12 weeks after the last actual dose of study drug</time_frame>
    <description>SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [&lt;LLOQ]) 12 weeks after the last dose of study drug.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Genotype 2 (GT2) Direct-acting Antiviral Agents (DAA)-Naive Participants (in Part 4, Arm S1) With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) as Compared to Historical Control</measure>
    <time_frame>12 weeks after the last actual dose of study drug</time_frame>
    <description>SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [&lt;LLOQ]) 12 weeks after the last dose of study drug.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Sustained Virologic Response 4 Weeks Post-treatment (SVR4)</measure>
    <time_frame>4 weeks after the last actual dose of study drug</time_frame>
    <description>SVR4 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [&lt;LLOQ]) 4 weeks after the last dose of study drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With On-treatment Virologic Failure</measure>
    <time_frame>Up to end of treatment (treatment week 8, 12 or 16 depending on arm) or premature discontinuation from treatment</time_frame>
    <description>On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA &lt; LLOQ during treatment; confirmed increase of &gt; 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Post-treatment Relapse</measure>
    <time_frame>From the end of treatment through 12 weeks after the last dose of study drug</time_frame>
    <description>Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels &lt; LLOQ at the end of treatment, excluding reinfection.</description>
  </secondary_outcome>
  <number_of_arms>22</number_of_arms>
  <enrollment type="Actual">694</enrollment>
  <condition>Chronic Hepatitis C</condition>
  <condition>Hepatitis C Virus</condition>
  <arm_group>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 2 (GT2) -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided twice daily (BID) for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm D</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 3 (GT3) -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm E</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm F</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided BID for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm G</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (40 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm H</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm I</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (40 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm J</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm K</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm L</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT3 -infected treatment naïve and for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm M</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (80 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm N</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (80 mg) QD and ribavirin (RBV) (800 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm O</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis and for 16 weeks in HCV GT3 -infected treatment-experienced participants with compensated cirrhosis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm P</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and RBV (800 mg) QD for 12 weeks in HCV GT3-infected treatment naïve and treatment-experienced participants with compensated cirrhosis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm Q1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment naïve participants with cirrhosis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm Q2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm R1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm R2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants with cirrhosis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm S1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT2 infected treatment naïve and treatment experienced participants without cirrhosis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm S2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT4-6 infected treatment naïve and treatment experienced participants without cirrhosis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ABT-493</intervention_name>
    <description>Tablet</description>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_label>Arm B</arm_group_label>
    <arm_group_label>Arm C</arm_group_label>
    <arm_group_label>Arm D</arm_group_label>
    <arm_group_label>Arm E</arm_group_label>
    <arm_group_label>Arm F</arm_group_label>
    <arm_group_label>Arm G</arm_group_label>
    <arm_group_label>Arm H</arm_group_label>
    <arm_group_label>Arm I</arm_group_label>
    <arm_group_label>Arm J</arm_group_label>
    <arm_group_label>Arm K</arm_group_label>
    <arm_group_label>Arm L</arm_group_label>
    <arm_group_label>Arm M</arm_group_label>
    <arm_group_label>Arm N</arm_group_label>
    <arm_group_label>Arm O</arm_group_label>
    <arm_group_label>Arm P</arm_group_label>
    <other_name>glecaprevir</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ABT-530</intervention_name>
    <description>Tablet</description>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_label>Arm B</arm_group_label>
    <arm_group_label>Arm C</arm_group_label>
    <arm_group_label>Arm D</arm_group_label>
    <arm_group_label>Arm E</arm_group_label>
    <arm_group_label>Arm F</arm_group_label>
    <arm_group_label>Arm G</arm_group_label>
    <arm_group_label>Arm H</arm_group_label>
    <arm_group_label>Arm I</arm_group_label>
    <arm_group_label>Arm J</arm_group_label>
    <arm_group_label>Arm K</arm_group_label>
    <arm_group_label>Arm L</arm_group_label>
    <arm_group_label>Arm M</arm_group_label>
    <arm_group_label>Arm N</arm_group_label>
    <arm_group_label>Arm O</arm_group_label>
    <arm_group_label>Arm P</arm_group_label>
    <other_name>pibrentasvir</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ribavirin (RBV)</intervention_name>
    <description>Tablet</description>
    <arm_group_label>Arm C</arm_group_label>
    <arm_group_label>Arm F</arm_group_label>
    <arm_group_label>Arm N</arm_group_label>
    <arm_group_label>Arm P</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ABT-493/ABT-530</intervention_name>
    <description>Tablet; ABT-493 co-formulated ABT-530</description>
    <arm_group_label>Arm Q1</arm_group_label>
    <arm_group_label>Arm Q2</arm_group_label>
    <arm_group_label>Arm R1</arm_group_label>
    <arm_group_label>Arm R2</arm_group_label>
    <arm_group_label>Arm S1</arm_group_label>
    <arm_group_label>Arm S2</arm_group_label>
    <other_name>ABT-493 also known as glecaprevir</other_name>
    <other_name>ABT-530 also known as pibrentasvir</other_name>
    <other_name>MAVYRET</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Screening laboratory result indicating HCV Genotype 2, 3, 4, 5, or 6 infection.&#xD;
&#xD;
          -  Chronic HCV infection.&#xD;
&#xD;
          -  Participant had to be either HCV treatment-naïve or treatment-experienced.&#xD;
&#xD;
          -  Participant had to be documented as non-cirrhotic or as having compensated cirrhosis&#xD;
             (GT3 only).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of severe, life-threatening or other significant sensitivity to any drug.&#xD;
&#xD;
          -  Female who was pregnant, planning to become pregnant during the study, or&#xD;
             breastfeeding; or male whose partner was pregnant or planning to become pregnant&#xD;
             during the study.&#xD;
&#xD;
          -  Recent (within 6 months prior to study drug administration) history of drug or alcohol&#xD;
             abuse that could preclude adherence to the protocol in the opinion of the&#xD;
             investigator.&#xD;
&#xD;
          -  Positive test result at Screening for hepatitis B surface antigen (HBsAg) or&#xD;
             anti-human immunodeficiency virus antibody (HIV Ab).&#xD;
&#xD;
          -  HCV genotype performed during screening indicating co-infection with more than one HCV&#xD;
             genotype.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>AbbVie Inc.</last_name>
    <role>Study Director</role>
    <affiliation>AbbVie</affiliation>
  </overall_official>
  <removed_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>France</country>
    <country>Italy</country>
    <country>Korea, Republic of</country>
    <country>New Zealand</country>
    <country>Taiwan</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </removed_countries>
  <link>
    <url>http://rxabbvie.com</url>
    <description>Related Info</description>
  </link>
  <reference>
    <citation>Kwo PY, Poordad F, Asatryan A, Wang S, Wyles DL, Hassanein T, Felizarta F, Sulkowski MS, Gane E, Maliakkal B, Overcash JS, Gordon SC, Muir AJ, Aguilar H, Agarwal K, Dore GJ, Lin CW, Liu R, Lovell SS, Ng TI, Kort J, Mensa FJ. Glecaprevir and pibrentasvir yield high response rates in patients with HCV genotype 1-6 without cirrhosis. J Hepatol. 2017 Aug;67(2):263-271. doi: 10.1016/j.jhep.2017.03.039. Epub 2017 Apr 13.</citation>
    <PMID>28412293</PMID>
  </reference>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <results_first_submitted>August 31, 2017</results_first_submitted>
  <results_first_submitted_qc>August 31, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">October 2, 2017</results_first_posted>
  <disposition_first_submitted>February 8, 2017</disposition_first_submitted>
  <disposition_first_submitted_qc>February 8, 2017</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">February 10, 2017</disposition_first_posted>
  <last_update_submitted>July 9, 2021</last_update_submitted>
  <last_update_submitted_qc>July 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hepatitis C Virus (HCV)</keyword>
  <keyword>Hepatitis C</keyword>
  <keyword>Chronic Hepatitis C</keyword>
  <keyword>interferon free</keyword>
  <keyword>Hepatitis C Genotype 2</keyword>
  <keyword>Hepatitis C Genotype 3</keyword>
  <keyword>Hepatitis C Genotype 4</keyword>
  <keyword>Hepatitis C Genotype 5</keyword>
  <keyword>Hepatitis C Genotype 6</keyword>
  <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>
    <mesh_term>Hepatitis, Chronic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ribavirin</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Enrollment into arms H, I, K, M and N was not opened by AbbVie.</recruitment_details>
      <pre_assignment_details>Intent-to-treat population: all participants who received at least 1 dose of study drug</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Arm A</title>
          <description>ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 2 (GT2) -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
        </group>
        <group group_id="P2">
          <title>Arm B</title>
          <description>ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
        </group>
        <group group_id="P3">
          <title>Arm C</title>
          <description>ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided twice daily (BID) for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
        </group>
        <group group_id="P4">
          <title>Arm D</title>
          <description>ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 3 (GT3) -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
        </group>
        <group group_id="P5">
          <title>Arm E</title>
          <description>ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
        </group>
        <group group_id="P6">
          <title>Arm F</title>
          <description>ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided BID for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
        </group>
        <group group_id="P7">
          <title>Arm G</title>
          <description>ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (40 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
        </group>
        <group group_id="P8">
          <title>Arm H</title>
          <description>ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
        </group>
        <group group_id="P9">
          <title>Arm I</title>
          <description>ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (40 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
        </group>
        <group group_id="P10">
          <title>Arm J</title>
          <description>ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
        </group>
        <group group_id="P11">
          <title>Arm K</title>
          <description>ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
        </group>
        <group group_id="P12">
          <title>Arm L</title>
          <description>ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT3 -infected treatment naïve and for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.</description>
        </group>
        <group group_id="P13">
          <title>Arm M</title>
          <description>ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (80 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis.</description>
        </group>
        <group group_id="P14">
          <title>Arm N</title>
          <description>ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (80 mg) QD and ribavirin (RBV) (800 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis.</description>
        </group>
        <group group_id="P15">
          <title>Arm O</title>
          <description>ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis and for 16 weeks in HCV GT3 -infected treatment-experienced participants with compensated cirrhosis.</description>
        </group>
        <group group_id="P16">
          <title>Arm P</title>
          <description>ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and RBV (800 mg) QD for 12 weeks in HCV GT3-infected treatment naïve and treatment-experienced participants with compensated cirrhosis.</description>
        </group>
        <group group_id="P17">
          <title>Arm Q1</title>
          <description>ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment naïve participants with cirrhosis.</description>
        </group>
        <group group_id="P18">
          <title>Arm Q2</title>
          <description>ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.</description>
        </group>
        <group group_id="P19">
          <title>Arm R1</title>
          <description>ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.</description>
        </group>
        <group group_id="P20">
          <title>Arm R2</title>
          <description>ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants with cirrhosis.</description>
        </group>
        <group group_id="P21">
          <title>Arm S1</title>
          <description>ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT2 infected treatment naïve and treatment experienced participants without cirrhosis.</description>
        </group>
        <group group_id="P22">
          <title>Arm S2</title>
          <description>ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT4-6 infected treatment naïve and treatment experienced participants without cirrhosis.</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="24"/>
                <participants group_id="P3" count="25"/>
                <participants group_id="P4" count="30"/>
                <participants group_id="P5" count="31"/>
                <participants group_id="P6" count="31"/>
                <participants group_id="P7" count="30"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="55"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="53"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="28"/>
                <participants group_id="P16" count="27"/>
                <participants group_id="P17" count="40"/>
                <participants group_id="P18" count="22"/>
                <participants group_id="P19" count="22"/>
                <participants group_id="P20" count="48"/>
                <participants group_id="P21" count="145"/>
                <participants group_id="P22" count="58"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="23"/>
                <participants group_id="P3" count="24"/>
                <participants group_id="P4" count="29"/>
                <participants group_id="P5" count="30"/>
                <participants group_id="P6" count="31"/>
                <participants group_id="P7" count="27"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="53"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="50"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="27"/>
                <participants group_id="P16" count="26"/>
                <participants group_id="P17" count="37"/>
                <participants group_id="P18" count="21"/>
                <participants group_id="P19" count="22"/>
                <participants group_id="P20" count="47"/>
                <participants group_id="P21" count="143"/>
                <participants group_id="P22" count="55"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="3"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="2"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="3"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="1"/>
                <participants group_id="P16" count="1"/>
                <participants group_id="P17" count="3"/>
                <participants group_id="P18" count="1"/>
                <participants group_id="P19" count="0"/>
                <participants group_id="P20" count="1"/>
                <participants group_id="P21" count="2"/>
                <participants group_id="P22" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="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="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="1"/>
                <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 group_id="P21" count="1"/>
                <participants group_id="P22" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="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="1"/>
                <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 group_id="P21" count="0"/>
                <participants group_id="P22" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="3"/>
                <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="2"/>
                <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="3"/>
                <participants group_id="P18" count="1"/>
                <participants group_id="P19" count="0"/>
                <participants group_id="P20" count="0"/>
                <participants group_id="P21" count="1"/>
                <participants group_id="P22" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Enrolled into a Re-treatment Study</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="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="1"/>
                <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 group_id="P21" count="0"/>
                <participants group_id="P22" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Randomized but did'nt receive study drug</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="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="1"/>
                <participants group_id="P21" count="0"/>
                <participants group_id="P22" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All participants who received atleast 1 dose of study drug (ITT population)</population>
      <group_list>
        <group group_id="B1">
          <title>Arm A</title>
          <description>ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 2 (GT2) -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
        </group>
        <group group_id="B2">
          <title>Arm B</title>
          <description>ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
        </group>
        <group group_id="B3">
          <title>Arm C</title>
          <description>ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided twice daily (BID) for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
        </group>
        <group group_id="B4">
          <title>Arm D</title>
          <description>ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 3 (GT3) -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
        </group>
        <group group_id="B5">
          <title>Arm E</title>
          <description>ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
        </group>
        <group group_id="B6">
          <title>Arm F</title>
          <description>ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided BID for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
        </group>
        <group group_id="B7">
          <title>Arm G</title>
          <description>ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (40 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
        </group>
        <group group_id="B8">
          <title>Arm J</title>
          <description>ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
        </group>
        <group group_id="B9">
          <title>Arm L</title>
          <description>ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT3 -infected treatment naïve and for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.</description>
        </group>
        <group group_id="B10">
          <title>Arm O</title>
          <description>ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis and for 16 weeks in HCV GT3 -infected treatment-experienced participants with compensated cirrhosis.</description>
        </group>
        <group group_id="B11">
          <title>Arm P</title>
          <description>ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and RBV (800 mg) QD for 12 weeks in HCV GT3-infected treatment naïve and treatment-experienced participants with compensated cirrhosis.</description>
        </group>
        <group group_id="B12">
          <title>Arm Q1</title>
          <description>ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment naïve participants with cirrhosis.</description>
        </group>
        <group group_id="B13">
          <title>Arm Q2</title>
          <description>ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.</description>
        </group>
        <group group_id="B14">
          <title>Arm R1</title>
          <description>ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.</description>
        </group>
        <group group_id="B15">
          <title>Arm R2</title>
          <description>ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants with cirrhosis.</description>
        </group>
        <group group_id="B16">
          <title>Arm S1</title>
          <description>ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT2 infected treatment naïve and treatment experienced participants without cirrhosis.</description>
        </group>
        <group group_id="B17">
          <title>Arm S2</title>
          <description>ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT4-6 infected treatment naïve and treatment experienced participants without cirrhosis.</description>
        </group>
        <group group_id="B18">
          <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="24"/>
            <count group_id="B3" value="25"/>
            <count group_id="B4" value="30"/>
            <count group_id="B5" value="30"/>
            <count group_id="B6" value="31"/>
            <count group_id="B7" value="30"/>
            <count group_id="B8" value="54"/>
            <count group_id="B9" value="53"/>
            <count group_id="B10" value="28"/>
            <count group_id="B11" value="27"/>
            <count group_id="B12" value="40"/>
            <count group_id="B13" value="22"/>
            <count group_id="B14" value="22"/>
            <count group_id="B15" value="47"/>
            <count group_id="B16" value="145"/>
            <count group_id="B17" value="58"/>
            <count group_id="B18" value="691"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>&lt; 65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="22"/>
                    <measurement group_id="B4" value="28"/>
                    <measurement group_id="B5" value="29"/>
                    <measurement group_id="B6" value="30"/>
                    <measurement group_id="B7" value="28"/>
                    <measurement group_id="B8" value="44"/>
                    <measurement group_id="B9" value="52"/>
                    <measurement group_id="B10" value="26"/>
                    <measurement group_id="B11" value="24"/>
                    <measurement group_id="B12" value="38"/>
                    <measurement group_id="B13" value="18"/>
                    <measurement group_id="B14" value="19"/>
                    <measurement group_id="B15" value="39"/>
                    <measurement group_id="B16" value="128"/>
                    <measurement group_id="B17" value="49"/>
                    <measurement group_id="B18" value="616"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;= 65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="10"/>
                    <measurement group_id="B9" value="1"/>
                    <measurement group_id="B10" value="2"/>
                    <measurement group_id="B11" value="3"/>
                    <measurement group_id="B12" value="2"/>
                    <measurement group_id="B13" value="4"/>
                    <measurement group_id="B14" value="3"/>
                    <measurement group_id="B15" value="8"/>
                    <measurement group_id="B16" value="17"/>
                    <measurement group_id="B17" value="9"/>
                    <measurement group_id="B18" value="75"/>
                  </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="9"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="11"/>
                    <measurement group_id="B5" value="16"/>
                    <measurement group_id="B6" value="12"/>
                    <measurement group_id="B7" value="15"/>
                    <measurement group_id="B8" value="21"/>
                    <measurement group_id="B9" value="21"/>
                    <measurement group_id="B10" value="13"/>
                    <measurement group_id="B11" value="9"/>
                    <measurement group_id="B12" value="16"/>
                    <measurement group_id="B13" value="8"/>
                    <measurement group_id="B14" value="8"/>
                    <measurement group_id="B15" value="11"/>
                    <measurement group_id="B16" value="84"/>
                    <measurement group_id="B17" value="21"/>
                    <measurement group_id="B18" value="293"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="19"/>
                    <measurement group_id="B5" value="14"/>
                    <measurement group_id="B6" value="19"/>
                    <measurement group_id="B7" value="15"/>
                    <measurement group_id="B8" value="33"/>
                    <measurement group_id="B9" value="32"/>
                    <measurement group_id="B10" value="15"/>
                    <measurement group_id="B11" value="18"/>
                    <measurement group_id="B12" value="24"/>
                    <measurement group_id="B13" value="14"/>
                    <measurement group_id="B14" value="14"/>
                    <measurement group_id="B15" value="36"/>
                    <measurement group_id="B16" value="61"/>
                    <measurement group_id="B17" value="37"/>
                    <measurement group_id="B18" value="398"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="5"/>
                    <measurement group_id="B7" value="5"/>
                    <measurement group_id="B8" value="6"/>
                    <measurement group_id="B9" value="2"/>
                    <measurement group_id="B10" value="4"/>
                    <measurement group_id="B11" value="2"/>
                    <measurement group_id="B12" value="9"/>
                    <measurement group_id="B13" value="1"/>
                    <measurement group_id="B14" value="0"/>
                    <measurement group_id="B15" value="4"/>
                    <measurement group_id="B16" value="11"/>
                    <measurement group_id="B17" value="2"/>
                    <measurement group_id="B18" value="65"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="21"/>
                    <measurement group_id="B4" value="26"/>
                    <measurement group_id="B5" value="27"/>
                    <measurement group_id="B6" value="26"/>
                    <measurement group_id="B7" value="25"/>
                    <measurement group_id="B8" value="48"/>
                    <measurement group_id="B9" value="51"/>
                    <measurement group_id="B10" value="24"/>
                    <measurement group_id="B11" value="25"/>
                    <measurement group_id="B12" value="31"/>
                    <measurement group_id="B13" value="21"/>
                    <measurement group_id="B14" value="22"/>
                    <measurement group_id="B15" value="43"/>
                    <measurement group_id="B16" value="134"/>
                    <measurement group_id="B17" value="56"/>
                    <measurement group_id="B18" value="626"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="0"/>
                    <measurement group_id="B14" value="0"/>
                    <measurement group_id="B15" value="0"/>
                    <measurement group_id="B16" value="0"/>
                    <measurement group_id="B17" value="0"/>
                    <measurement group_id="B18" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)</title>
        <description>SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [&lt;LLOQ]) 12 weeks after the last dose of study drug.</description>
        <time_frame>12 weeks after the last actual dose of study drug</time_frame>
        <population>All participants who received at least 1 dose of study drug (ITT population) with evaluable data; participants with missing data after backwards imputation were imputed as nonresponders.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm A</title>
            <description>ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 2 (GT2) -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
          </group>
          <group group_id="O2">
            <title>Arm B</title>
            <description>ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
          </group>
          <group group_id="O3">
            <title>Arm C</title>
            <description>ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided twice daily (BID) for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
          </group>
          <group group_id="O4">
            <title>Arm D</title>
            <description>ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 3 (GT3) -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
          </group>
          <group group_id="O5">
            <title>Arm E</title>
            <description>ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
          </group>
          <group group_id="O6">
            <title>Arm F</title>
            <description>ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided BID for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
          </group>
          <group group_id="O7">
            <title>Arm G</title>
            <description>ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (40 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
          </group>
          <group group_id="O8">
            <title>Arm J</title>
            <description>ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
          </group>
          <group group_id="O9">
            <title>Arm L</title>
            <description>ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT3 -infected treatment naïve and for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.</description>
          </group>
          <group group_id="O10">
            <title>Arm O</title>
            <description>ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis and for 16 weeks in HCV GT3 -infected treatment-experienced participants with compensated cirrhosis.</description>
          </group>
          <group group_id="O11">
            <title>Arm P</title>
            <description>ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and RBV (800 mg) QD for 12 weeks in HCV GT3-infected treatment naïve and treatment-experienced participants with compensated cirrhosis.</description>
          </group>
          <group group_id="O12">
            <title>Arm Q1</title>
            <description>ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment naïve participants with cirrhosis.</description>
          </group>
          <group group_id="O13">
            <title>Arm Q2</title>
            <description>ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.</description>
          </group>
          <group group_id="O14">
            <title>Arm R1</title>
            <description>ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.</description>
          </group>
          <group group_id="O15">
            <title>Arm R2</title>
            <description>ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants with cirrhosis.</description>
          </group>
          <group group_id="O16">
            <title>Arm S1</title>
            <description>ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT2 infected treatment naïve and treatment experienced participants without cirrhosis.</description>
          </group>
          <group group_id="O17">
            <title>Arm S2</title>
            <description>ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT4-6 infected treatment naïve and treatment experienced participants without cirrhosis.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)</title>
          <description>SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [&lt;LLOQ]) 12 weeks after the last dose of study drug.</description>
          <population>All participants who received at least 1 dose of study drug (ITT population) with evaluable data; participants with missing data after backwards imputation were imputed as nonresponders.</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="24"/>
                <count group_id="O3" value="25"/>
                <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="54"/>
                <count group_id="O9" value="53"/>
                <count group_id="O10" value="28"/>
                <count group_id="O11" value="27"/>
                <count group_id="O12" value="40"/>
                <count group_id="O13" value="22"/>
                <count group_id="O14" value="22"/>
                <count group_id="O15" value="47"/>
                <count group_id="O16" value="145"/>
                <count group_id="O17" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.0" lower_limit="80.5" upper_limit="99.3"/>
                    <measurement group_id="O2" value="100.0" lower_limit="86.2" upper_limit="100.0"/>
                    <measurement group_id="O3" value="100.0" lower_limit="86.7" upper_limit="100.0"/>
                    <measurement group_id="O4" value="93.3" lower_limit="78.7" upper_limit="98.2"/>
                    <measurement group_id="O5" value="93.3" lower_limit="78.7" upper_limit="98.2"/>
                    <measurement group_id="O6" value="93.5" lower_limit="79.3" upper_limit="98.2"/>
                    <measurement group_id="O7" value="83.3" lower_limit="66.4" upper_limit="92.7"/>
                    <measurement group_id="O8" value="98.1" lower_limit="90.2" upper_limit="99.7"/>
                    <measurement group_id="O9" value="94.3" lower_limit="84.6" upper_limit="98.1"/>
                    <measurement group_id="O10" value="96.4" lower_limit="82.3" upper_limit="99.4"/>
                    <measurement group_id="O11" value="100.0" lower_limit="87.5" upper_limit="100.0"/>
                    <measurement group_id="O12" value="97.5" lower_limit="87.1" upper_limit="99.6"/>
                    <measurement group_id="O13" value="90.9" lower_limit="72.2" upper_limit="97.5"/>
                    <measurement group_id="O14" value="95.5" lower_limit="78.2" upper_limit="99.2"/>
                    <measurement group_id="O15" value="95.7" lower_limit="85.8" upper_limit="98.8"/>
                    <measurement group_id="O16" value="97.9" lower_limit="94.1" upper_limit="99.3"/>
                    <measurement group_id="O17" value="93.1" lower_limit="83.6" upper_limit="97.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Genotype 2 (GT2) Direct-acting Antiviral Agents (DAA)-Naive Participants (in Part 4, Arm S1) With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) as Compared to Historical Control</title>
        <description>SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [&lt;LLOQ]) 12 weeks after the last dose of study drug.</description>
        <time_frame>12 weeks after the last actual dose of study drug</time_frame>
        <population>All participants who received at least 1 dose of study drug (ITT population) with evaluable data; participants with missing data after backwards imputation were imputed as nonresponders.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm S1</title>
            <description>ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT2 infected treatment naïve and treatment experienced participants without cirrhosis.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Genotype 2 (GT2) Direct-acting Antiviral Agents (DAA)-Naive Participants (in Part 4, Arm S1) With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) as Compared to Historical Control</title>
          <description>SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [&lt;LLOQ]) 12 weeks after the last dose of study drug.</description>
          <population>All participants who received at least 1 dose of study drug (ITT population) with evaluable data; participants with missing data after backwards imputation were imputed as nonresponders.</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="137"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.5" lower_limit="96.5" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The non-inferiority of the rate of sustained virologic response at 12 weeks after treatment as compared to historical control (in genotype 2 (GT2) DAA-naive participants in Part 4, arm S) was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 89% to achieve noninferiority.</non_inferiority_desc>
            <param_type>Percentage of Participants</param_type>
            <param_value>98.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>96.5</ci_lower_limit>
            <ci_upper_limit>100.0</ci_upper_limit>
            <estimate_desc>95% CI was calculated using the normal approximation to the binomial distribution.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Sustained Virologic Response 4 Weeks Post-treatment (SVR4)</title>
        <description>SVR4 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [&lt;LLOQ]) 4 weeks after the last dose of study drug.</description>
        <time_frame>4 weeks after the last actual dose of study drug</time_frame>
        <population>All participants who received at least 1 dose of study drug (ITT population) with evaluable data; participants with missing data after backwards imputation were imputed as nonresponders.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm A</title>
            <description>ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 2 (GT2) -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
          </group>
          <group group_id="O2">
            <title>Arm B</title>
            <description>ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
          </group>
          <group group_id="O3">
            <title>Arm C</title>
            <description>ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided twice daily (BID) for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
          </group>
          <group group_id="O4">
            <title>Arm D</title>
            <description>ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 3 (GT3) -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
          </group>
          <group group_id="O5">
            <title>Arm E</title>
            <description>ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
          </group>
          <group group_id="O6">
            <title>Arm F</title>
            <description>ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided BID for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
          </group>
          <group group_id="O7">
            <title>Arm G</title>
            <description>ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (40 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
          </group>
          <group group_id="O8">
            <title>Arm J</title>
            <description>ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
          </group>
          <group group_id="O9">
            <title>Arm L</title>
            <description>ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT3 -infected treatment naïve and for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.</description>
          </group>
          <group group_id="O10">
            <title>Arm O</title>
            <description>ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis and for 16 weeks in HCV GT3 -infected treatment-experienced participants with compensated cirrhosis.</description>
          </group>
          <group group_id="O11">
            <title>Arm P</title>
            <description>ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and RBV (800 mg) QD for 12 weeks in HCV GT3-infected treatment naïve and treatment-experienced participants with compensated cirrhosis.</description>
          </group>
          <group group_id="O12">
            <title>Arm Q1</title>
            <description>ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment naïve participants with cirrhosis.</description>
          </group>
          <group group_id="O13">
            <title>Arm Q2</title>
            <description>ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.</description>
          </group>
          <group group_id="O14">
            <title>Arm R1</title>
            <description>ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.</description>
          </group>
          <group group_id="O15">
            <title>Arm R2</title>
            <description>ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants with cirrhosis.</description>
          </group>
          <group group_id="O16">
            <title>Arm S1</title>
            <description>ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT2 infected treatment naïve and treatment experienced participants without cirrhosis.</description>
          </group>
          <group group_id="O17">
            <title>Arm S2</title>
            <description>ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT4-6 infected treatment naïve and treatment experienced participants without cirrhosis.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Sustained Virologic Response 4 Weeks Post-treatment (SVR4)</title>
          <description>SVR4 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [&lt;LLOQ]) 4 weeks after the last dose of study drug.</description>
          <population>All participants who received at least 1 dose of study drug (ITT population) with evaluable data; participants with missing data after backwards imputation were imputed as nonresponders.</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="24"/>
                <count group_id="O3" value="25"/>
                <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="54"/>
                <count group_id="O9" value="53"/>
                <count group_id="O10" value="28"/>
                <count group_id="O11" value="27"/>
                <count group_id="O12" value="40"/>
                <count group_id="O13" value="22"/>
                <count group_id="O14" value="22"/>
                <count group_id="O15" value="47"/>
                <count group_id="O16" value="145"/>
                <count group_id="O17" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.0" lower_limit="80.5" upper_limit="99.3"/>
                    <measurement group_id="O2" value="100.0" lower_limit="86.2" upper_limit="100.0"/>
                    <measurement group_id="O3" value="100.0" lower_limit="86.7" upper_limit="100.0"/>
                    <measurement group_id="O4" value="93.3" lower_limit="78.7" upper_limit="98.2"/>
                    <measurement group_id="O5" value="93.3" lower_limit="78.7" upper_limit="98.2"/>
                    <measurement group_id="O6" value="93.5" lower_limit="79.3" upper_limit="98.2"/>
                    <measurement group_id="O7" value="93.3" lower_limit="78.7" upper_limit="98.2"/>
                    <measurement group_id="O8" value="98.1" lower_limit="90.2" upper_limit="99.7"/>
                    <measurement group_id="O9" value="96.2" lower_limit="87.2" upper_limit="99.0"/>
                    <measurement group_id="O10" value="96.4" lower_limit="82.3" upper_limit="99.4"/>
                    <measurement group_id="O11" value="100.0" lower_limit="87.5" upper_limit="100.0"/>
                    <measurement group_id="O12" value="97.5" lower_limit="87.1" upper_limit="99.6"/>
                    <measurement group_id="O13" value="95.5" lower_limit="78.2" upper_limit="99.2"/>
                    <measurement group_id="O14" value="95.5" lower_limit="78.2" upper_limit="99.2"/>
                    <measurement group_id="O15" value="95.7" lower_limit="85.8" upper_limit="98.8"/>
                    <measurement group_id="O16" value="97.9" lower_limit="94.1" upper_limit="99.3"/>
                    <measurement group_id="O17" value="98.3" lower_limit="90.9" upper_limit="99.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With On-treatment Virologic Failure</title>
        <description>On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA &lt; LLOQ during treatment; confirmed increase of &gt; 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.</description>
        <time_frame>Up to end of treatment (treatment week 8, 12 or 16 depending on arm) or premature discontinuation from treatment</time_frame>
        <population>All participants who received at least 1 dose of study drug (ITT population) with evaluable data.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm A</title>
            <description>ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 2 (GT2) -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
          </group>
          <group group_id="O2">
            <title>Arm B</title>
            <description>ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
          </group>
          <group group_id="O3">
            <title>Arm C</title>
            <description>ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided twice daily (BID) for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
          </group>
          <group group_id="O4">
            <title>Arm D</title>
            <description>ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 3 (GT3) -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
          </group>
          <group group_id="O5">
            <title>Arm E</title>
            <description>ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
          </group>
          <group group_id="O6">
            <title>Arm F</title>
            <description>ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided BID for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
          </group>
          <group group_id="O7">
            <title>Arm G</title>
            <description>ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (40 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
          </group>
          <group group_id="O8">
            <title>Arm J</title>
            <description>ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
          </group>
          <group group_id="O9">
            <title>Arm L</title>
            <description>ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT3 -infected treatment naïve and for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.</description>
          </group>
          <group group_id="O10">
            <title>Arm O</title>
            <description>ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis and for 16 weeks in HCV GT3 -infected treatment-experienced participants with compensated cirrhosis.</description>
          </group>
          <group group_id="O11">
            <title>Arm P</title>
            <description>ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and RBV (800 mg) QD for 12 weeks in HCV GT3-infected treatment naïve and treatment-experienced participants with compensated cirrhosis.</description>
          </group>
          <group group_id="O12">
            <title>Arm Q1</title>
            <description>ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment naïve participants with cirrhosis.</description>
          </group>
          <group group_id="O13">
            <title>Arm Q2</title>
            <description>ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.</description>
          </group>
          <group group_id="O14">
            <title>Arm R1</title>
            <description>ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.</description>
          </group>
          <group group_id="O15">
            <title>Arm R2</title>
            <description>ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants with cirrhosis.</description>
          </group>
          <group group_id="O16">
            <title>Arm S1</title>
            <description>ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT2 infected treatment naïve and treatment experienced participants without cirrhosis.</description>
          </group>
          <group group_id="O17">
            <title>Arm S2</title>
            <description>ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT4-6 infected treatment naïve and treatment experienced participants without cirrhosis.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With On-treatment Virologic Failure</title>
          <description>On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA &lt; LLOQ during treatment; confirmed increase of &gt; 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.</description>
          <population>All participants who received at least 1 dose of study drug (ITT population) with evaluable data.</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="24"/>
                <count group_id="O3" value="25"/>
                <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="54"/>
                <count group_id="O9" value="53"/>
                <count group_id="O10" value="28"/>
                <count group_id="O11" value="27"/>
                <count group_id="O12" value="40"/>
                <count group_id="O13" value="22"/>
                <count group_id="O14" value="22"/>
                <count group_id="O15" value="47"/>
                <count group_id="O16" value="145"/>
                <count group_id="O17" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0.0" upper_limit="13.3"/>
                    <measurement group_id="O2" value="0" lower_limit="0.0" upper_limit="13.8"/>
                    <measurement group_id="O3" value="0" lower_limit="0.0" upper_limit="13.3"/>
                    <measurement group_id="O4" value="0" lower_limit="0.0" upper_limit="11.4"/>
                    <measurement group_id="O5" value="0" lower_limit="0.0" upper_limit="11.4"/>
                    <measurement group_id="O6" value="3.2" lower_limit="0.6" upper_limit="16.2"/>
                    <measurement group_id="O7" value="3.3" lower_limit="0.6" upper_limit="16.7"/>
                    <measurement group_id="O8" value="0" lower_limit="0.0" upper_limit="6.6"/>
                    <measurement group_id="O9" value="1.9" lower_limit="0.3" upper_limit="9.9"/>
                    <measurement group_id="O10" value="0" lower_limit="0.0" upper_limit="12.1"/>
                    <measurement group_id="O11" value="0" lower_limit="0.0" upper_limit="12.5"/>
                    <measurement group_id="O12" value="0" lower_limit="0.0" upper_limit="8.8"/>
                    <measurement group_id="O13" value="0" lower_limit="0.0" upper_limit="14.9"/>
                    <measurement group_id="O14" value="0" lower_limit="0.0" upper_limit="14.9"/>
                    <measurement group_id="O15" value="2.1" lower_limit="0.4" upper_limit="11.1"/>
                    <measurement group_id="O16" value="0" lower_limit="0.0" upper_limit="2.6"/>
                    <measurement group_id="O17" value="0" lower_limit="0.0" upper_limit="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Post-treatment Relapse</title>
        <description>Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels &lt; LLOQ at the end of treatment, excluding reinfection.</description>
        <time_frame>From the end of treatment through 12 weeks after the last dose of study drug</time_frame>
        <population>All participants who received at least 1 dose of study drug (ITT population) with evaluable data, completed treatment, and had HCV RNA &lt;LLOQ at the final treatment visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm A</title>
            <description>ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 2 (GT2) -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
          </group>
          <group group_id="O2">
            <title>Arm B</title>
            <description>ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
          </group>
          <group group_id="O3">
            <title>Arm C</title>
            <description>ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided twice daily (BID) for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
          </group>
          <group group_id="O4">
            <title>Arm D</title>
            <description>ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 3 (GT3) -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
          </group>
          <group group_id="O5">
            <title>Arm E</title>
            <description>ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
          </group>
          <group group_id="O6">
            <title>Arm F</title>
            <description>ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided BID for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
          </group>
          <group group_id="O7">
            <title>Arm G</title>
            <description>ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (40 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
          </group>
          <group group_id="O8">
            <title>Arm J</title>
            <description>ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
          </group>
          <group group_id="O9">
            <title>Arm L</title>
            <description>ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT3 -infected treatment naïve and for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.</description>
          </group>
          <group group_id="O10">
            <title>Arm O</title>
            <description>ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis and for 16 weeks in HCV GT3 -infected treatment-experienced participants with compensated cirrhosis.</description>
          </group>
          <group group_id="O11">
            <title>Arm P</title>
            <description>ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and RBV (800 mg) QD for 12 weeks in HCV GT3-infected treatment naïve and treatment-experienced participants with compensated cirrhosis.</description>
          </group>
          <group group_id="O12">
            <title>Arm Q1</title>
            <description>ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment naïve participants with cirrhosis.</description>
          </group>
          <group group_id="O13">
            <title>Arm Q2</title>
            <description>ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.</description>
          </group>
          <group group_id="O14">
            <title>Arm R1</title>
            <description>ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.</description>
          </group>
          <group group_id="O15">
            <title>Arm R2</title>
            <description>ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants with cirrhosis.</description>
          </group>
          <group group_id="O16">
            <title>Arm S1</title>
            <description>ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT2 infected treatment naïve and treatment experienced participants without cirrhosis.</description>
          </group>
          <group group_id="O17">
            <title>Arm S2</title>
            <description>ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT4-6 infected treatment naïve and treatment experienced participants without cirrhosis.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Post-treatment Relapse</title>
          <description>Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels &lt; LLOQ at the end of treatment, excluding reinfection.</description>
          <population>All participants who received at least 1 dose of study drug (ITT population) with evaluable data, completed treatment, and had HCV RNA &lt;LLOQ at the final treatment visit.</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="24"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="25"/>
                <count group_id="O4" value="29"/>
                <count group_id="O5" value="30"/>
                <count group_id="O6" value="28"/>
                <count group_id="O7" value="28"/>
                <count group_id="O8" value="53"/>
                <count group_id="O9" value="51"/>
                <count group_id="O10" value="28"/>
                <count group_id="O11" value="27"/>
                <count group_id="O12" value="39"/>
                <count group_id="O13" value="22"/>
                <count group_id="O14" value="22"/>
                <count group_id="O15" value="46"/>
                <count group_id="O16" value="144"/>
                <count group_id="O17" value="57"/>
              </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="13.8"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="13.8"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="13.3"/>
                    <measurement group_id="O4" value="3.4" lower_limit="0.6" upper_limit="17.2"/>
                    <measurement group_id="O5" value="6.7" lower_limit="1.8" upper_limit="21.3"/>
                    <measurement group_id="O6" value="0.0" lower_limit="0.0" upper_limit="12.1"/>
                    <measurement group_id="O7" value="7.1" lower_limit="2.0" upper_limit="22.6"/>
                    <measurement group_id="O8" value="0.0" lower_limit="0.0" upper_limit="6.8"/>
                    <measurement group_id="O9" value="2.0" lower_limit="0.3" upper_limit="10.3"/>
                    <measurement group_id="O10" value="3.6" lower_limit="0.6" upper_limit="17.7"/>
                    <measurement group_id="O11" value="0.0" lower_limit="0.0" upper_limit="12.5"/>
                    <measurement group_id="O12" value="0" lower_limit="0.0" upper_limit="9.0"/>
                    <measurement group_id="O13" value="9.1" lower_limit="2.5" upper_limit="27.8"/>
                    <measurement group_id="O14" value="4.5" lower_limit="0.8" upper_limit="21.8"/>
                    <measurement group_id="O15" value="2.2" lower_limit="0.4" upper_limit="11.3"/>
                    <measurement group_id="O16" value="1.4" lower_limit="0.4" upper_limit="4.9"/>
                    <measurement group_id="O17" value="0" lower_limit="0.0" upper_limit="6.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 20 weeks).</time_frame>
      <desc>TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.</desc>
      <group_list>
        <group group_id="E1">
          <title>ARM A</title>
          <description>ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 2 (GT2) -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
        </group>
        <group group_id="E2">
          <title>ARM B</title>
          <description>ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
        </group>
        <group group_id="E3">
          <title>ARM C</title>
          <description>ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided twice daily (BID) for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
        </group>
        <group group_id="E4">
          <title>ARM D</title>
          <description>ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 3 (GT3) -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
        </group>
        <group group_id="E5">
          <title>ARM E</title>
          <description>ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
        </group>
        <group group_id="E6">
          <title>ARM F</title>
          <description>ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided BID for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
        </group>
        <group group_id="E7">
          <title>ARM G</title>
          <description>ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (40 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
        </group>
        <group group_id="E8">
          <title>ARM J</title>
          <description>ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.</description>
        </group>
        <group group_id="E9">
          <title>ARM L</title>
          <description>ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT3 -infected treatment naïve and for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.</description>
        </group>
        <group group_id="E10">
          <title>ARM O</title>
          <description>ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis and for 16 weeks in HCV GT3 -infected treatment-experienced participants with compensated cirrhosis.</description>
        </group>
        <group group_id="E11">
          <title>ARM P</title>
          <description>ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and RBV (800 mg) QD for 12 weeks in HCV GT3-infected treatment naïve and treatment-experienced participants with compensated cirrhosis.</description>
        </group>
        <group group_id="E12">
          <title>ARM Q1</title>
          <description>ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment naïve participants with cirrhosis.</description>
        </group>
        <group group_id="E13">
          <title>ARM Q2</title>
          <description>ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.</description>
        </group>
        <group group_id="E14">
          <title>ARM R1</title>
          <description>ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.</description>
        </group>
        <group group_id="E15">
          <title>ARM R2</title>
          <description>ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants with cirrhosis.</description>
        </group>
        <group group_id="E16">
          <title>ARM S1</title>
          <description>ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT2 infected treatment naïve and treatment experienced participants without cirrhosis.</description>
        </group>
        <group group_id="E17">
          <title>ARM S2</title>
          <description>ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT4-6 infected treatment naïve and treatment experienced participants without cirrhosis.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA version 19.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="3" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Umbilical hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Tibia fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>B-cell lymphoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Colon cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Hepatic neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of skin</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Delusional disorder, unspecified type</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Schizophrenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA version 19.0</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="12" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="22" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="19" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="20" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="23" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="18" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="26" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="40" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="20" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="21" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="30" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="12" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="13" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="31" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="78" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="32" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="4" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="2" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="3" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="2" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="4" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="8" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="6" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="4" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="4" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="2" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="3" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="4" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="2" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="2" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="11" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="5" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="4" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="7" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="4" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="5" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="18" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="5" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="4" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="2" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Energy increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="12" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="7" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="15" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="8" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="5" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="4" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="4" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="16" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="24" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="13" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Feeling hot</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="3" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="6" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="3" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Tooth abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="4" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="5" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="2" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="10" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="3" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="7" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Blood bilirubin unconjugated increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Haematocrit decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Haemoglobin decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="2" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="3" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="3" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="2" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="3" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="4" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="4" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="6" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="2" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="3" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="2" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="4" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="3" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="2" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="4" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="4" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="7" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="2" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="3" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="5" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="6" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="17" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="5" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="9" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="10" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="5" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="4" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="6" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="17" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="11" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="3" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="6" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="2" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="4" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Emotional disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="5" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="5" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="3" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="2" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="4" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="2" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Mood swings</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="3" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="3" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="5" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="4" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="2" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Respiratory tract congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="4" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="3" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="53"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E16" subjects_affected="2" subjects_at_risk="145"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="58"/>
              </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>AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Global Medical Services</name_or_title>
      <organization>AbbVie</organization>
      <phone>800-633-9110</phone>
      <email>abbvieclinicaltrials@abbvie.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/NCT02243293
org study id: M14-868
secondary id: 2014-002927-90
nct id: NCT02243293
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this phase 2/3, open-label, multipart, multicenter study was to evaluate the
      efficacy, and safety of co-administration of ABT-493 and ABT-530 with and without ribavirin
      (RBV) in chronic HCV genotype 2 (GT2-), genotype 3 (GT3-), genotype 4 (GT4), genotype 5
      (GT5-), or genotype 6 (GT6-) infected participants with or without cirrhosis.
The study consisted of four independent parts with treatment and post-treatment periods of
      enrollment. Parts 1 and 2 were the supportive/ exploratory parts (phase 2) of the study and
      part 3 and 4 were the confirmatory/ registrational parts (phase 3) of the study. In parts 1
      and 2 of the study, ABT-493 and ABT-530 were co-administered as separate tablets. However, in
      parts 3 and 4 of the study, the ABT-493/ABT-530 co-formulated tablets were administered.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
time frame: 12 weeks after the last actual dose of study drug
description: SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.
measure: Percentage of Genotype 2 (GT2) Direct-acting Antiviral Agents (DAA)-Naive Participants (in Part 4, Arm S1) With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) as Compared to Historical Control
time frame: 12 weeks after the last actual dose of study drug
description: SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.
measure: Percentage of Participants With Sustained Virologic Response 4 Weeks Post-treatment (SVR4)
time frame: 4 weeks after the last actual dose of study drug
description: SVR4 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 4 weeks after the last dose of study drug.
measure: Percentage of Participants With On-treatment Virologic Failure
time frame: Up to end of treatment (treatment week 8, 12 or 16 depending on arm) or premature discontinuation from treatment
description: On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.
measure: Percentage of Participants With Post-treatment Relapse
time frame: From the end of treatment through 12 weeks after the last dose of study drug
description: Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment, excluding reinfection.
arm group label: Arm A
arm group type: Experimental
description: ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 2 (GT2) -infected treatment naïve and treatment experienced participants without cirrhosis.
arm group label: Arm B
arm group type: Experimental
description: ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.
arm group label: Arm C
arm group type: Experimental
description: ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided twice daily (BID) for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.
arm group label: Arm D
arm group type: Experimental
description: ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 3 (GT3) -infected treatment naïve and treatment experienced participants without cirrhosis.
arm group label: Arm E
arm group type: Experimental
description: ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.
arm group label: Arm F
arm group type: Experimental
description: ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided BID for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.
arm group label: Arm G
arm group type: Experimental
description: ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (40 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.
arm group label: Arm H
arm group type: Experimental
description: ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.
arm group label: Arm I
arm group type: Experimental
description: ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (40 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.
arm group label: Arm J
arm group type: Experimental
description: ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.
arm group label: Arm K
arm group type: Experimental
description: ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.
arm group label: Arm L
arm group type: Experimental
description: ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT3 -infected treatment naïve and for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.
arm group label: Arm M
arm group type: Experimental
description: ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (80 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis.
arm group label: Arm N
arm group type: Experimental
description: ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (80 mg) QD and ribavirin (RBV) (800 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis.
arm group label: Arm O
arm group type: Experimental
description: ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis and for 16 weeks in HCV GT3 -infected treatment-experienced participants with compensated cirrhosis.
arm group label: Arm P
arm group type: Experimental
description: ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and RBV (800 mg) QD for 12 weeks in HCV GT3-infected treatment naïve and treatment-experienced participants with compensated cirrhosis.
arm group label: Arm Q1
arm group type: Experimental
description: ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment naïve participants with cirrhosis.
arm group label: Arm Q2
arm group type: Experimental
description: ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.
arm group label: Arm R1
arm group type: Experimental
description: ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.
arm group label: Arm R2
arm group type: Experimental
description: ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants with cirrhosis.
arm group label: Arm S1
arm group type: Experimental
description: ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT2 infected treatment naïve and treatment experienced participants without cirrhosis.
arm group label: Arm S2
arm group type: Experimental
description: ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT4-6 infected treatment naïve and treatment experienced participants without cirrhosis.
intervention type: Drug
intervention name: ABT-493
description: Tablet
arm group label: Arm A
arm group label: Arm B
arm group label: Arm C
arm group label: Arm D
arm group label: Arm E
arm group label: Arm F
arm group label: Arm G
arm group label: Arm H
arm group label: Arm I
arm group label: Arm J
arm group label: Arm K
arm group label: Arm L
arm group label: Arm M
arm group label: Arm N
arm group label: Arm O
arm group label: Arm P
other name: glecaprevir
intervention type: Drug
intervention name: ABT-530
description: Tablet
arm group label: Arm A
arm group label: Arm B
arm group label: Arm C
arm group label: Arm D
arm group label: Arm E
arm group label: Arm F
arm group label: Arm G
arm group label: Arm H
arm group label: Arm I
arm group label: Arm J
arm group label: Arm K
arm group label: Arm L
arm group label: Arm M
arm group label: Arm N
arm group label: Arm O
arm group label: Arm P
other name: pibrentasvir
intervention type: Drug
intervention name: ribavirin (RBV)
description: Tablet
arm group label: Arm C
arm group label: Arm F
arm group label: Arm N
arm group label: Arm P
intervention type: Drug
intervention name: ABT-493/ABT-530
description: Tablet; ABT-493 co-formulated ABT-530
arm group label: Arm Q1
arm group label: Arm Q2
arm group label: Arm R1
arm group label: Arm R2
arm group label: Arm S1
arm group label: Arm S2
other name: ABT-493 also known as glecaprevir
other name: ABT-530 also known as pibrentasvir
other name: MAVYRET
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: AbbVie Inc.
role: Study Director
affiliation: AbbVie
country: Australia
country: Canada
country: France
country: Italy
country: Korea, Republic of
country: New Zealand
country: Taiwan
country: United Kingdom
country: United States
url: http://rxabbvie.com
description: Related Info
citation: Kwo PY, Poordad F, Asatryan A, Wang S, Wyles DL, Hassanein T, Felizarta F, Sulkowski MS, Gane E, Maliakkal B, Overcash JS, Gordon SC, Muir AJ, Aguilar H, Agarwal K, Dore GJ, Lin CW, Liu R, Lovell SS, Ng TI, Kort J, Mensa FJ. Glecaprevir and pibrentasvir yield high response rates in patients with HCV genotype 1-6 without cirrhosis. J Hepatol. 2017 Aug;67(2):263-271. doi: 10.1016/j.jhep.2017.03.039. Epub 2017 Apr 13.
PMID: 28412293
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis C, Chronic
mesh term: Hepatitis
mesh term: Hepatitis, Chronic
mesh term: Ribavirin
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 